Childrens Allergy
Diphenhydramine Hydrochloride
Demoulas Market Basket
Human Otc Drug
NDC 53942-505Childrens Allergy also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Demoulas Market Basket'. National Drug Code (NDC) number for Childrens Allergy is 53942-505. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Allergy drug includes Diphenhydramine Hydrochloride - 12.5 mg/5mL . The currest status of Childrens Allergy drug is Active.
Drug Information:
| Drug NDC: | 53942-505 |
| 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: | Childrens Allergy |
| 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: | Demoulas Market Basket |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 12.5 mg/5mL
|
| 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 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: | 11 Sep, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | part336 |
| 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: | DeMoulas Market Basket
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049906
|
| 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. |
| 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 |
|---|
| 53942-505-24 | 118 mL in 1 BOTTLE (53942-505-24) | 11 Sep, 2012 | 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 antihistamine
Product Elements:
Childrens allergy diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine citric acid monohydrate d&c red no. 33 fd&c red no. 40 glycerin poloxamer 407 water sodium benzoate sodium chloride sodium citrate sucrose
Indications and Usage:
Uses ⢠temporarily relieves these symptoms due to hay fever or other respiratory allergies: ⢠sneezing ⢠itching of the nose or throat ⢠runny nose ⢠itchy watery eyes ⢠temporarily relieves these symptoms due to the common cold: ⢠sneezing ⢠runny nose
Warnings:
Warnings do not use ⢠with any other product containing diphenhydramine, even one used on skin ⢠to make a child sleepy
When Using:
When using this product ⢠marked drowsiness may occur ⢠excitability may occur, especially in children ⢠sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions ⢠if needed, take every 4-6 hours ⢠do not take more than 6 doses in 24 hours children under 4 years of age: do not use children 4 to under 6 years of age: do not use unless directed by a doctor children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)
Package Label Principal Display Panel:
Product label âmore for your dollarâ market basket ® *compare to the active ingredient in benadryl® allergy liquid childrenâs allergy diphenhydramine hcl oral solution antihistamine relieves: ⢠sneezing ⢠runny nose ⢠itchy watery eyes ⢠itchy throat alcohol-free cherry flavor 4 fl oz (118 ml) lot: exp: do not use if printed seal under cap is torn or missing *this product is not manufactured or distributed by mcneil-ppc, inc. distributer of benadryl® allergy liquid. distributed by demoulas supermarkets inc. 875 east street tewksbury ma 01876 bx-014 rev 01 aptapharmmb childallergy aptapharmmb childallergy 1
Further Questions:
Questions or comments? call weekdays from 9:30 am to 4:30 pm est at 1-877-798-5944