Benzocaine Raspberry
Benzocaine
Darby Dental Supply, Llc
Human Otc Drug
NDC 66467-4000Benzocaine Raspberry also known as Benzocaine is a human otc drug labeled by 'Darby Dental Supply, Llc'. National Drug Code (NDC) number for Benzocaine Raspberry is 66467-4000. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Benzocaine Raspberry drug includes Benzocaine - 220 mg/g . The currest status of Benzocaine Raspberry drug is Active.
Drug Information:
| Drug NDC: | 66467-4000 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Benzocaine Raspberry |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Benzocaine |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Raspberry |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Benzocaine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Darby Dental Supply, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BENZOCAINE - 220 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Feb, 1963 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Darby Dental Supply, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000185508
N0000175629
N0000184306
M0000728
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | U3RSY48JW5
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Standardized Chemical Allergen [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Allergens [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Allergens [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Standardized Chemical Allergen [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 66467-4000-2 | 30 g in 1 JAR (66467-4000-2) | 19 Feb, 1963 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose oral anesthetic
Product Elements:
Benzocaine cherry benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine benzocaine mint benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine benzocaine bubble gum benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine benzocaine strawberry benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine benzocaine raspberry benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine benzocaine pina colada benzocaine water fd&c blue no. 1 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 benzocaine benzocaine dye free pina colada
Indications and Usage:
Use for oral mucosal use only, as directed by dentist. for the temporary relief of pain due to minor dental procedures.
Warnings:
Warnings methemoglobinemia warning use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. do not use for more than 7 days unless directed by a physician. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age when using this product avoid contact with eyes. if contact occurs, flush with wa
Read more...ter. do not exceed recommended dosage. if more than used for pain is accidentally swallowed, get medical help or contact a poison control center right away. if pregnant or breast feeding, ask a physician before use. keep out of reach of children.
Do Not Use:
Warnings methemoglobinemia warning use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. do not use for more than 7 days unless directed by a physician. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age when using this product avoid contact with eyes. if contact occurs, flush with water. do not exceed recommended dosage. if more than used for pain is accidentally swallowed, get medical help or contact a poison control center right away. if pregnant or breast feeding, ask a physician before use. keep out of reach of children.
When Using:
When using this product avoid contact with eyes. if contact occurs, flush with water.
Dosage and Administration:
Directions apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Package Label Principal Display Panel:
Principal display panel - 1 oz jar label - cherry darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - cherry
Principal display panel - 1 oz jar label - mint darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - mint
Principal display panel - 1 oz jar label - bubble gum darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - bubble gum
Principal display panel - 1 oz jar label - strawberry darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - strawberry
Principal display panel - 1 oz jar label - raspberry darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - raspberry
Principal display panel - 1 oz jar label - pina colada darby ® darby dental supply, llc 20% benzocaine gel topical anesthetic gel net contents: 1 oz darby quality certified manufactured for: darby dental supply, llc jericho, ny 11753 peel back to review drug facts principal display panel - 1 oz jar label - pina colada
Further Questions:
Questions or comments? 800-645-2310 or darby.com