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 91 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TARGET Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	bfc91c71-0506-4e94-8bfe-dc9e4bf959da	2025-11-07	Warnings	Exact identifier application number: M012
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	H E B	08f4785a-c628-4e9b-9412-b2a817f9be60	2025-11-07	Warnings	Exact identifier application number: M012
G-TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	d169585f-b4f4-4831-8c71-e1533ae7e7c4	2025-11-07	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	1d512053-7a54-4691-a657-77da4c627cb8	2025-11-07	Warnings	Exact identifier application number: M012
Allergy and Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dc249163-26dd-42ca-b423-2f16299f2d65	2025-11-07	Warnings	Exact identifier application number: M012
Sinus Congestion	PSEUDOEPHEDRINE HCL	Chain Drug Marketing Association, Inc.	9744d04d-298d-4acd-9470-db9e7f2901e7	2025-11-07	Warnings	Exact identifier application number: M012
Daytime, Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159	2025-11-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e	2025-11-07	Warnings	Exact identifier application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	The Procter & Gamble Manufacturing Company	ff0bffee-9a36-8246-e053-6294a90a86c7	2025-11-06	Warnings	Exact identifier application number: M012
Xlear Nasal Decongestant	NASAL SPRAY	Xlear Inc.	1c1db71a-47d0-42ac-8cbe-95e76dca185f	2025-11-06	Warnings	Exact identifier application number: M012
Robitussin Honey Cough DM Day Night Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	1bbd0157-06e6-4a3b-bac9-91ac879ba089	2025-11-06	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant Phenylephrine HCl	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	21676b0c-6be2-464c-ae91-92e5f0d0087d	2025-11-06	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	04715af5-e861-496c-834a-233eb7312556	2025-11-06	Warnings	Exact identifier application number: M012
Severe Allergy Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	1a1f41c4-5430-4cff-873e-6547dadc8779	2025-11-06	Warnings	Exact identifier application number: M012
Target Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	05e944d5-3473-4d8c-8df4-2ffc7474e9fa	2025-11-05	Warnings	Exact identifier application number: M012
Target Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	TARGET CORPORATION	e36f179e-5aed-4fee-8b0a-767bf3590752	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2	2025-11-05	Warnings	Exact identifier application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	f007beaa-b108-46d5-8a98-853f011a8e2e	2025-11-05	Warnings	Exact identifier application number: M012
Target Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	TARGET CORPORATION	975e157a-8f8d-41ad-b55b-9f9100188ccd	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL	TARGET CORPORATION	6e94fdab-27ea-4c0f-a91c-735ce697304b	2025-11-05	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