Childrens Mucinex Cough

Product NDC: 63824-281
11-digit product format: 638240281
Labeler code: 63824
Product ID: 63824-281_f55f7917-4250-47d0-9ec7-27f2e2eaae42
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: LIQUID
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-01
Marketing end: 0000-00-00
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 100 mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63824-281		I	Inactivated by FDA		2026-10-05
excluded package	package	63824-281	63824-281-64	I	Inactivated by FDA		2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-281-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-281-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-281-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-281-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-281-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-281-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-281-64	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-281-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-281-64	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-281-64	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-281-64	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63824-281-64	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63824-281-64	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63824-281-64	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63824-281-64	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63824-281-64	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63824-281-64	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63824-281-64	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-281-64	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-281-64	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-281-64	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

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
63824-281-64	2020-01-31	C162847	48780-1	9d75b9d0-3af3-f424-e053-dadaa90a57ce	Children's Mucinex® Cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-281-64	Childrens Mucinex Cough	1 in 1 CARTON	LIQUID	1		2
63824-281-64	Childrens Mucinex Cough	118 mL in 1 BOTTLE	LIQUID	118		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-281-64	ML - Milliliter	63824-281	8e9c45cc-2a62-41e9-8dff-fddf6ebf3839	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-281	CHILDRENS MUCINEX COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RECKITT BENCKISER LLC]	2	Legacy NDC, 2 package rows	20121113_ce565113-e9e3-46de-84f7-3a432acb0e4b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	ce565113-e9e3-46de-84f7-3a432acb0e4b	2
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	ce565113-e9e3-46de-84f7-3a432acb0e4b	2
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	ce565113-e9e3-46de-84f7-3a432acb0e4b	2
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	ce565113-e9e3-46de-84f7-3a432acb0e4b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63824-281-64	63824028164	1 in 1 CARTON	Historical