Robitussin

Product NDC: 0031-2103
11-digit product format: 000312103
Labeler code: 0031
Product ID: 0031-2103_430487ce-fbd6-66fc-e063-6294a90a32bf
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 Maximum Strength Cough DM
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
b43d8fbd-1977-4465-aa64-79e7b7f54e09	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
0031-2103-01	RobitussinDay and Night Maximum Strength Cough DM	1 in 1 CARTON	KIT	1		1
0031-8718-13	RobitussinDay and Night Maximum Strength Cough DM	1 in 1 CARTON	SOLUTION		12.5 mg in 20mL	1
0031-8718-13	RobitussinDay and Night Maximum Strength Cough DM	118 mL in 1 BOTTLE	SOLUTION	118 mL	30 mg in 20mL	1
0031-8739-12	RobitussinDay and Night Maximum Strength Cough DM	118 mL in 1 BOTTLE	SOLUTION	118 mL	20 mg in 20mL	1
0031-8739-12	RobitussinDay and Night Maximum Strength Cough DM	1 in 1 CARTON	SOLUTION		400 mg in 20mL	1

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 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	HEB	3a30a427-6ab4-24ae-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat and Cough Lozenges	BENZOCAINE	HEB	3063ea93-6bc2-1d18-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
HEB Menthol Cough Drops	MENTHOL	HEB	c197855d-15b4-38fc-e053-2a95a90a2dc7	2025-12-13	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	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
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	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
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	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0031-2103-01	00031210301	1 KIT in 1 CARTON (0031-2103-01) * 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE	1 kit	2021-03-01	No	No	Current
0031-8718-13	00031871813	1 in 1 CARTON					Historical
0031-8739-12	00031873912	118 mL in 1 BOTTLE	118 ml				Historical