Robitussin Maximum Strength Nighttime Cough DM

Product NDC: 0031-8718
11-digit product format: 000318718
Labeler code: 0031
Product ID: 0031-8718_42637453-ec82-913e-e063-6294a90af911
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Maximum Strength Nighttime Cough DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/20mL
DOXYLAMINE SUCCINATE	12.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115329	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
44feee2f-25bc-48d4-8e13-db1d9daaaa90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8718-13	Robitussin Maximum Strength Nighttime Cough DM	1 in 1 CARTON	SOLUTION	1		10
0031-8718-13	Robitussin Maximum Strength Nighttime Cough DM	118 mL in 1 BOTTLE	SOLUTION	118		10
0031-8718-18	Robitussin Maximum Strength Nighttime Cough DM	237 mL in 1 BOTTLE	SOLUTION	237		10
0031-8718-18	Robitussin Maximum Strength Nighttime Cough DM	1 in 1 CARTON	SOLUTION	1		10
0031-8718-24	Robitussin Maximum Strength Nighttime Cough DM	355 mL in 1 BOTTLE	SOLUTION	355		10
0031-8718-24	Robitussin Maximum Strength Nighttime Cough DM	1 in 1 CARTON	SOLUTION	1		10
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
0031-8718-13	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8718-13	ML - Milliliter	0031-8718	17cf427c-d526-4213-b309-8d0e9c33ec19	1	2019-02-13
0031-8718-18	ML - Milliliter	0031-8718	bebdbba5-3b06-4073-8d1c-fa1ffe74fd46	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8718	ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]	9	Current NDC, Legacy NDC, 6 package rows	20250315_44feee2f-25bc-48d4-8e13-db1d9daaaa90.zip
0031-8718	ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [HALEON US HOLDINGS LLC]	2	Current NDC, Legacy NDC	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 93 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	WAL-MART STORES,INC.	68a68574-0fcb-4569-be57-d9aee5f62bea	2025-10-28	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	635009a1-6154-4c62-a4be-d4f32c2cef8d	2025-10-28	Warnings	Exact identifier application number: M012
Publix Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	cf49a06d-f095-48bf-bcd2-a410066ff9af	2025-10-28	Warnings	Exact identifier application number: M012
Publix	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	283e42b9-173c-4deb-9377-ff649efc177f	2025-10-28	Warnings	Exact identifier application number: M012
Publix Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	eae83b75-9d5a-4100-9304-629e54ef7752	2025-10-28	Warnings	Exact identifier application number: M012
Publix	PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	f10e120d-f0b7-4c51-b29b-e8cdbb1456f3	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0f8e9e-0503-522b-e053-2a91aa0aca35	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0eef2f-f546-d769-e053-2991aa0a8fe4	2025-10-28	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Congestion Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	P & L Development, LLC	4af67ba7-8892-442c-b9fb-80aba9140e05	2025-10-28	Warnings	Exact identifier application number: M012
No Drip Nasal Mist Nasal Decongestant Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	994fa270-65bb-4097-b88a-d5ce3c0e1c79	2025-10-27	Warnings	Exact identifier application number: M012
Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	WAL-MART STORES INC.	3652ee94-b762-4100-a305-5acbec5f795a	2025-10-27	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Cold,Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	Wal-Mart Stores,Inc.,	2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc	2025-10-27	Warnings	Exact identifier application number: M012
Allergies MY CHILD NEEDS HELP WITH	DIPHENHYDRAMINE HCL	Unconditional Love	5ad293e9-0a4b-4923-8a91-f01450726828	2025-10-27	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	4a9fd615-b7d3-452c-ac40-d9189124faaa	2025-10-24	Warnings	Exact identifier application number: M012
allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	622b12fa-455c-4432-a9a2-698a929bbd68	2025-10-24	Warnings	Exact identifier application number: M012
Dristan 12 hr	OXYMETAZOLINE HYDROCHLORIDE	Foundation Consumer Brands	522876fe-a412-4ca8-bfad-a313e3cbc1af	2025-10-24	Warnings	Exact identifier application number: M012
Dimetapp Multi-Symptom Cold and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	178fe95b-e1ed-43b2-e063-6294a90a7a78	2025-10-24	Warnings	Exact identifier application number: M012
Menthol Drops Dollar General Severe 45ct	MENTHOL	Dollar General Corporation	c831d3d9-b910-40e6-bfdf-defe6850614d	2025-10-24	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	7d2f3292-bb73-41dc-9729-edb83670be1b	2025-10-24	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol 30ct	MENTHOL	R.L. ALBERT & SON, INC	b174e57c-4e4f-4842-b8f2-f1b067764a68	2025-10-24	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	44feee2f-25bc-48d4-8e13-db1d9daaaa90	10
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	44feee2f-25bc-48d4-8e13-db1d9daaaa90	10
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	44feee2f-25bc-48d4-8e13-db1d9daaaa90	10
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	44feee2f-25bc-48d4-8e13-db1d9daaaa90	10
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
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	Marketing end	Sample	Exclude flag	Status
0031-8718-13	00031871813	1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current
0031-8718-18	00031871818	1 BOTTLE in 1 CARTON (0031-8718-18) / 237 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current
0031-8718-24	00031871824	1 BOTTLE in 1 CARTON (0031-8718-24) / 355 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2025-11-07	HUMAN OTC DRUG LABEL	1
Drug Facts	Haleon US Holdings LLC	2025-10-30	HUMAN OTC DRUG LABEL	10
Drug Facts	Haleon US Holdings LLC	2025-10-30	HUMAN OTC DRUG LABEL	4