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 147 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sinus pressure and pain pe	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a7931e4c-8a5e-66e2-e053-2995a90af2a4	2024-10-18	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	570ea130-6a99-446e-9f97-14fc95809006	2024-10-18	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a14999e3-a9d9-0a1f-e053-2995a90af7b3	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a793000b-3ef9-5662-e053-2a95a90ad0da	2024-10-18	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime and Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	37455f86-ab21-472b-9e80-40324699f3ca	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3396a27-8643-71fa-e053-2a95a90a713d	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3397f69-3267-ca0b-e053-2995a90a7db5	2024-10-18	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	747512a2-3b6d-496b-ab80-819060314163	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	9daf7f40-d9c5-4367-be41-894208358fc1	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	608e6808-29e4-40bc-8496-24c092681a1b	2024-10-18	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	665db127-ee04-46c4-bff0-e0fe9950c3e2	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8	2024-10-18	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	604d7e53-4bfd-4cdd-aed2-b304ae82ce44	2024-10-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	4d93a703-c905-4fb3-b772-11c207065d4d	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	62c35320-87b5-46e2-9f6f-cb0882bdb52e	2024-10-17	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dcf6cf-373c-ea83-e053-2a95a90ae57a	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5918-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5916-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
ALLERGY MULTISYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e9ab8e-2252-180d-e053-2a95a90a788f	2024-10-17	Warnings	Exact identifier application number: M012
COLD PLUS HEAD CONGESTION SEVERE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	3430c7e4-e142-407e-bed5-358dd6bd10f7	2024-10-17	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