Mucinex Childrens Cough and Congestion

Product NDC: 63824-947
11-digit product format: 638240947
Labeler code: 63824
Product ID: 63824-947_5219f3a4-ccd0-d4ae-e063-6294a90a26d2
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: SUSPENSION
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-30
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	63824-947		I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-947	63824-947-11	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mucinex Childrens Cough and Congestion
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
GUAIFENESIN	100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-947-11	2020-06-16	C162847	48780-1	9d75b9d0-d516-f424-e053-dadaa90a57ce	Mucinex® Children's Cough & Congestion
63824-947-11	2020-01-31	C162847	48780-1	9d75b9d0-d516-f424-e053-dadaa90a57ce	Mucinex® Children's Cough & Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-947-11	Mucinex Childrens Cough and Congestion	1 in 1 CARTON	SUSPENSION	1		7
63824-947-11	Mucinex Childrens Cough and Congestion	201 mL in 1 BOTTLE	SUSPENSION	201		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-947-11	ML - Milliliter	63824-947	580f6bd1-0a5f-4e6f-b8c6-cd01cfa4e66b	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-947	MUCINEX CHILDRENS COUGH AND CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [RB HEALTH (US) LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241222_d9e5a8d7-814c-4ab1-bb05-e4cb9155978e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 26 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI	Reckitt Benckiser LLC	fdb70793-5dd1-0455-e053-6394a90ac621	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	3270f369-7a40-186d-e063-6394a90a8526	2026-05-19	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-947-11	63824094711	1 BOTTLE in 1 CARTON (63824-947-11) / 201 mL in 1 BOTTLE	1 bottle	2018-03-30	0000-00-00	No	No	Current