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 144 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	1deb60f3-e9be-4756-b0c1-527ef00dc741	2024-10-24	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	51dd467b-aae8-41fa-e054-00144ff8d46c	2024-10-24	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	68a5930b-37db-439d-8fb9-7d7de07d8465	2024-10-24	Warnings	Exact identifier application number: M012
sinus pressure pain and cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	bb0225d5-6c32-2c64-e053-2995a90a829b	2024-10-24	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148	2024-10-24	Warnings	Exact identifier application number: M012
CareOne Fast Acting Nasal	PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5	2024-10-24	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	8cb0d0c8-c565-4c5a-97c5-8250a67e23a8	2024-10-24	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	0d07a534-c67f-4041-a07c-ed7f68dfc426	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	90977b39-8ced-46bf-9d06-15306bce9b35	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2325f33-e4e4-1269-e053-2995a90ab4ac	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a8240d98-f0b0-3ded-e053-2a95a90a5cf9	2024-10-23	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a82401f5-65b1-11e9-e053-2a95a90a499e	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a823db21-4863-45a6-e053-2995a90ab8e6	2024-10-23	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2346d0c-75cf-974c-e053-2a95a90a2857	2024-10-23	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Marc Glassman, Inc.	ce573785-f77d-4314-9b7a-ef3f1f4f34d8	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a3dcc-45b4-4093-e053-2995a90a3b14	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a7cc5-bd0e-b92b-e053-2995a90af50a	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	1cd26a6a-4b50-4610-9fc8-278545d77f18	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	c5dd40e5-b4e2-4963-9a53-b71da1ed5510	2024-10-23	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