Robitussin

Product NDC: 0031-2834
11-digit product format: 000312834
Labeler code: 0031
Product ID: 0031-2834_42637c25-c581-e5d5-e063-6394a90af1b5
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-01
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Robitussin
Brand name suffix: Day and Night Cough Relief DM Max
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020138	Internal RxNorm lookup
1115329	Internal RxNorm lookup
2056073	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b3d02c91-8f79-4eb4-a378-1072474c572c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-2834-01	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	KIT	1		4
0031-8718-18	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	SOLUTION		12.5 mg in 20mL	4
0031-8718-18	RobitussinDay and Night Cough Relief DM Max	237 mL in 1 BOTTLE	SOLUTION	237 mL	30 mg in 20mL	4
0031-8739-12	RobitussinDay and Night Cough Relief DM Max	118 mL in 1 BOTTLE	SOLUTION	391 mL	400 mg in 20mL	4
0031-8739-12	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	SOLUTION		400 mg in 20mL	4
0031-8739-18	RobitussinDay and Night Cough Relief DM Max	237 mL in 1 BOTTLE	SOLUTION	391 mL	20 mg in 20mL	4
0031-8739-18	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	SOLUTION		400 mg in 20mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-2834	ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [HALEON US HOLDINGS LLC]	2	Current NDC, 7 package rows	20250507_b3d02c91-8f79-4eb4-a378-1072474c572c.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 107 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTIDOGESIC	DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN	ACTIPHARMA, LLC	697da3f9-9888-4d41-ba83-87ca9bf1e54b	2025-08-18	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rite Aid Corporation	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	2025-08-18	Warnings	Exact identifier application number: M012
MAJOR NASAL DECONGESTANT	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	4b78b9af-0975-43f8-8b44-daddef0478be	2025-08-15	Warnings	Exact identifier application number: M012
Dr Simi Mucus Relief Expectorant	GUAIFENESIN	Farmacias De Similares TX LLC	3c6d0e75-a685-6020-e063-6294a90a5c1b	2025-08-15	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	25bf4390-23f7-4bb6-b86e-c40eaf8d92da	2025-08-15	Warnings	Exact identifier application number: M012
Childrens Chewable Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2cac72be-4830-ad49-e063-6394a90a7832	2025-08-14	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AMERISOURCE BERGEN	2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e	2025-08-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walmart Inc.	16fae164-28db-8ef1-e063-6294a90ab5da	2025-08-12	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	fbece335-a7e5-4732-a086-561b23741579	2025-08-12	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	779ddb89-b6e2-4bfb-bcb5-8c7ec916675a	2025-08-12	Warnings	Exact identifier application number: M012
Equaline Nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	d7fa1720-eac4-4e82-9401-77215ce4f545	2025-08-12	Warnings	Exact identifier application number: M012
Diabetic Tussin DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	MEDTECH PRODUCTS INC	a10a3b33-7503-4334-8ed7-2bb881df4327	2025-08-08	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Exact identifier application number: M012
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	2025-08-06	Warnings	Exact identifier application number: M012
childrens cold cough dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Publix Super Markets Inc	6efe7097-2a99-4654-9d94-b47f2e64d19d	2025-08-05	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Chain Drug Marketing Association, Inc.	3b7548ee-7cd3-62c3-e063-6294a90a0612	2025-08-03	Warnings	Exact identifier application number: M012
Vaporizing chest rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	LJ Pharma	065bb666-e482-4e96-ac75-c6577dcc5b48	2025-08-01	Warnings	Exact identifier application number: M012
Nighttime Cough-Kids	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Genexa	024bb864-4214-1d8b-e063-6394a90aa573	2025-08-01	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Pharmadel LLC	3b53e5fc-f258-c2b9-e063-6394a90ab500	2025-08-01	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2056073	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	b3d02c91-8f79-4eb4-a378-1072474c572c	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	b3d02c91-8f79-4eb4-a378-1072474c572c	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0031-2834-01	00031283401	1 KIT in 1 CARTON (0031-2834-01) * 1 BOTTLE in 1 CARTON (0031-8739-18) / 237 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8718-18) / 237 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE	1 kit	2021-03-01	No	No	Current
0031-8718-18	00031871818	1 in 1 CARTON					Historical
0031-8739-12	00031873912	118 mL in 1 BOTTLE	118 ml				Historical
0031-8739-18	00031873918	237 mL in 1 BOTTLE	237 ml				Historical