0363-6020 NDC - DYE FREEINFANTS PAIN AND FEVER (ACETAMINOPHEN)

Drug Information

Product NDC: 0363-6020
Proprietary Name: Dye FreeInfants Pain and Fever
Non Proprietary Name: acetaminophen
Active Ingredient(s): 160 mg/5mL ACETAMINOPHEN
Administration Route(s): ORAL
Dosage Form(s): SUSPENSION

Labeler Information

Field Name	Field Value
Labeler Name:	WALGREEN COMPANY
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M013
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	10/10/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	0363-6020-02	1 BOTTLE in 1 CARTON (0363-6020-02) / 60 mL in 1 BOTTLE

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0363-6020	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.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Product 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.
PROPRIETARY NAME	Dye FreeInfants Pain and Fever	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	acetaminophen	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.
DOSAGE FORM NAME	SUSPENSION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	10/10/2022	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.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	Product 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 NUMBER	M013	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.
LABELER NAME	WALGREEN COMPANY	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACETAMINOPHEN	The translation of the dosage form Code submitted by the firm.
ACTIVE NUMERATOR STRENGTH	160
ACTIVE INGRED UNIT	mg/5mL

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 1/2/2026

Previous Code

Next Code