Tecnu Calagel
Diphenhydramine Hydrochloride
Tec Laboratories Inc.
Human Otc Drug
NDC 51879-802Tecnu Calagel also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Tec Laboratories Inc.'. National Drug Code (NDC) number for Tecnu Calagel is 51879-802. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Tecnu Calagel drug includes Diphenhydramine Hydrochloride - 20 mg/g . The currest status of Tecnu Calagel drug is Active.
Drug Information:
| Drug NDC: | 51879-802 |
| 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: | Tecnu Calagel |
| 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: | Diphenhydramine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tec Laboratories Inc. |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 20 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 20 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 Jun, 2026 |
| 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: | part348 |
| 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: | Tec Laboratories Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049880
2174801
|
| 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: | 0083926860019
|
| UPC stands for Universal Product Code. |
| UNII: | TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 51879-802-06 | 1 BOTTLE in 1 CARTON (51879-802-06) / 178.9 g in 1 BOTTLE (51879-802-66) | 20 Jun, 2019 | N/A | No |
| 51879-802-44 | 144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16) | 23 Jul, 2019 | N/A | No |
| 51879-802-66 | 178.9 g in 1 BOTTLE (51879-802-66) | 20 Jun, 2019 | 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 topical analgesic / antihistamine
Product Elements:
Tecnu calagel diphenhydramine hydrochloride polysorbate 20 zinc acetate hypromellose 2208 (100 mpa.s) water menthol, unspecified form benzethonium chloride sodium metabisulfite bisulfite ion edetate disodium edetic acid diphenhydramine hydrochloride diphenhydramine
Indications and Usage:
For temporary relief of pain and itching associated with: â¢minor burns â¢sunburn â¢minor cuts â¢scrapes â¢insect bites â¢minor skin irritations rashes due to: â¢poison oak â¢poison ivy â¢poison sumac
Warnings:
Do not use: â¢if allergic to sulfites â¢on children under 2 years of age unless directed by a doctor â¢with any other products containing diphenydramine, even one taken by mouth â¢on deep puncture wounds, animal bites or serious burns unless directed by a doctor â¢on large areas of the body
Dosage and Administration:
Directions â¢do not use more often than directed â¢adults and children 2 years of age and older â¢cleanse skin with soap and warm water and dry affected area â¢apply to affected area not more than 3 times daily â¢may be covered with a sterile bandage, if bandaged, let dry first â¢children under 2 years of age do not use, consult a doctor
Stop Use:
Stop use and ask a doctor if: â¢condition worsens â¢symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Calagel
Calagel pop
Calagel dispenser
Further Questions:
Questions? call 1-800-482-4464 serious side effects may be reported to this number.