63824-944 NDC - MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK (ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN)

Drug Information

Product NDC: 63824-944
Proprietary Name: Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack
Non Proprietary Name: Acetaminophen, Diphenylhydramine Hydrochloride, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Guaifenesin
Active Ingredient(s):
Administration Route(s):
Dosage Form(s): KIT

Labeler Information

Field Name	Field Value
Labeler Name:	RB Health (US) LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M012
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	5/25/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	63824-944-34	1 KIT in 1 CARTON (63824-944-34) * 1 BOTTLE in 1 CARTON (63824-949-01) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (63824-950-21) / 118 mL in 1 BOTTLE

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63824-944	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	Indicates 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 NAME	Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	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, Diphenylhydramine Hydrochloride, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Guaifenesin	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	KIT	The translation of the dosage form Code submitted by the firm.
START MARKETING DATE	5/25/2022	This is the date that the labeler indicates was the start of its marketing of the drug product.
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	M012	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	RB Health (US) LLC	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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