Sore Throat
Phenol
Rite Aid Corporation
Human Otc Drug
NDC 11822-3109Sore Throat also known as Phenol is a human otc drug labeled by 'Rite Aid Corporation'. National Drug Code (NDC) number for Sore Throat is 11822-3109. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Sore Throat drug includes Phenol - 1.4 g/100mL . The currest status of Sore Throat drug is Active.
Drug Information:
| Drug NDC: | 11822-3109 |
| 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: | Sore Throat |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Phenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rite Aid Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | PHENOL - 1.4 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 08 Oct, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | Rite Aid Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198776
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0011822310987
|
| UPC stands for Universal Product Code. |
| UNII: | 339NCG44TV
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11822-3109-8 | 177 mL in 1 BOTTLE, SPRAY (11822-3109-8) | 08 Oct, 2021 | 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/analgesic
Product Elements:
Sore throat phenol phenol phenol alcohol fd&c red no. 40 glycerin water saccharin sodium anhydrous
Indications and Usage:
Uses temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation
Warnings:
Warnings sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. ask a doctor promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. when using this product, do not exceed recommended dose. stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product, do not exceed recommended dose.
Dosage and Administration:
Directions adults and children 6 years and older apply to affected area (one spray) allow to remain in place for at least 15 second, then spit out use every 2 hours as directed by a doctor or dentist children under 12 years of age should be supervised in the use of this product children under 6 years of age, consult a doctor or dentist
Stop Use:
Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in chloraseptic®* sore throat spray phenol 1.4% oral anesthetic/analgestic relieves sore throat alcohol 0.10% aspirin free sugar free cherry flavor fl oz (ml) *this product is not manufactured or distributed by prestige brands, inc., distributor of chloraseptic®. tamper evident: do not use if iprinted safety seal around cap is broken or missing. distributed by: rite aid, 30 hunter lane camp hill, pa 17011
Package label rite aid sore throat spray cherry flavor phenol 1.4%