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 143 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier application number: M012
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	Warnings	Exact identifier application number: M012
Severe Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	d40d6fd1-3f84-40ae-ab7e-04569eb41617	2024-10-30	Warnings	Exact identifier application number: M012
equaline nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	4e0c6ad6-81ef-4b0e-b2eb-44256faf7358	2024-10-30	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fbe2c0-7749-4c8a-e063-6394a90a7c6e	2024-10-30	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	130e68d1-9048-49c1-beee-490eecaed2d9	2024-10-30	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	02f3e739-3153-412f-b2cd-6f01dcd5875b	2024-10-30	Warnings	Exact identifier application number: M012
HealthWise Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	25a19d3e-37b3-50d5-e063-6394a90a97d1	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23a03-6110-f595-e063-6394a90a70fe	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23e5e-302a-7b7f-e063-6294a90a0463	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Pharmadel LLC	25a26adf-fd90-bf57-e063-6294a90a4073	2024-10-29	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	e82dac83-2910-44dc-e053-2995a90a38e1	2024-10-29	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