Drug Information

Product NDC: 41250-631

Proprietary Name: Childrens Pain and Fever

Non Proprietary Name: Acetaminophen

Active Ingredient(s):
  • 160 mg/5mL ACETAMINOPHEN

Administration Route(s): ORAL

Dosage Form(s): SUSPENSION

Labeler Information

Labeler Name: Meijer Distribution Inc
Product Type: HUMAN OTC DRUG
FDA Application Number: part343
Start Marketing Date:5/5/1998

Package Information

No. Package Code Package Description Billing Unit
141250-631-261 BOTTLE in 1 CARTON (41250-631-26) > 118 mL in 1 BOTTLE
241250-631-342 BOTTLE in 1 CARTON (41250-631-34) > 118 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC41250-631The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEChildrens Pain and FeverThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAcetaminophenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/5/1998This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/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.
APPLICATION NUMBERpart343This 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.
LABELER NAMEMeijer Distribution IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 9/11/2020