Robitussin Maximum Strength Severe Cough Plus Sore Throat

Product NDC: 0031-8750
11-digit product format: 000318750
Labeler code: 0031
Product ID: 0031-8750_4380fed9-2211-3875-e063-6394a90ab5ea
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hydrobromide
Dosage form: LIQUID
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-04-10
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 650; 20 mg/20mL; mg/20mL
Pharmacologic classes: 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 Severe Cough Plus Sore Throat
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1919076	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
6a6f5da8-6433-4284-8df7-2d5b099b74dc	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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0031-8750-12	Robitussin Maximum Strength Severe Cough Plus Sore Throat	118 mL in 1 BOTTLE	LIQUID	118	11
0031-8750-12	Robitussin Maximum Strength Severe Cough Plus Sore Throat	1 in 1 CARTON	LIQUID	1	11
0031-8750-18	Robitussin Maximum Strength Severe Cough Plus Sore Throat	1 in 1 CARTON	LIQUID	1	11
0031-8750-18	Robitussin Maximum Strength Severe Cough Plus Sore Throat	237 mL in 1 BOTTLE	LIQUID	237	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8750-12	ML - Milliliter	0031-8750	999c0b22-960e-42da-9a18-a0948763bc9e	1	2020-05-08
0031-8750-18	ML - Milliliter	0031-8750	cf497560-869d-468f-ad8a-e65a1bb6460e	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8750	ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 4 package rows	20250515_6a6f5da8-6433-4284-8df7-2d5b099b74dc.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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Exact identifier application number: M012
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	e0e2b117-62bc-4132-9f7c-fe2a912052b1	2025-12-31	Warnings	Exact identifier application number: M012
Bio-Z-Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Advanced Generic Corporation	05e70eab-1467-4b09-991e-ef03f222e021	2025-12-31	Warnings	Exact identifier application number: M012
Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Alternative Pharmacal Corporation	fd00c41d-0580-4177-afaa-60bb12ca5a09	2025-12-31	Warnings	Exact identifier application number: M012
Ninjacof-D	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	Centurion Labs, LLC	5188aa20-41f1-4998-81e1-f4de055874bc	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	4743e562-1217-50ab-e063-6394a90af88d	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier application number: M012
Geri Care Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICAL CORP	4744669c-7f33-e35f-e063-6394a90a79b7	2025-12-31	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Exact identifier application number: M012
GeriCare Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICALS, CORP	47451cd8-7aab-90e2-e063-6394a90ad1b7	2025-12-31	Warnings	Exact identifier application number: M012
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Bestco Inc.	77e25027-3c96-21fa-e053-2991aa0a1f31	2025-12-31	Warnings	Exact identifier application number: M012
Puregen Labs Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	4745d4f9-bbdf-a4a6-e063-6294a90a15b2	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2a46ea9b-29e9-5197-e063-6394a90abc73	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77e50410-306d-b2fb-e053-2a91aa0af3c5	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	e086a6d2-f664-454e-9524-f656bfbf45df	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77f45efb-8ee0-1186-e053-2991aa0a9884	2025-12-31	Warnings	Exact identifier application number: M012
Conex Pediatric	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a46af43-ef36-e14e-e063-6394a90a8285	2025-12-31	Warnings	Exact identifier application number: M012
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1919076	acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution	PSN	6a6f5da8-6433-4284-8df7-2d5b099b74dc	11
1919076	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution	SCD	6a6f5da8-6433-4284-8df7-2d5b099b74dc	11
1919076	acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution	SY	6a6f5da8-6433-4284-8df7-2d5b099b74dc	11
1919076	acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Solution	SY	6a6f5da8-6433-4284-8df7-2d5b099b74dc	11
1919076	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution	SY	6a6f5da8-6433-4284-8df7-2d5b099b74dc	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8750-12	00031875012	1 BOTTLE in 1 CARTON (0031-8750-12) / 118 mL in 1 BOTTLE	1 bottle	2017-04-10	0000-00-00	No	No	Current
0031-8750-18	00031875018	1 BOTTLE in 1 CARTON (0031-8750-18) / 237 mL in 1 BOTTLE	1 bottle	2017-04-10	0000-00-00	No	No	Current