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 144 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	1deb60f3-e9be-4756-b0c1-527ef00dc741	2024-10-24	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	51dd467b-aae8-41fa-e054-00144ff8d46c	2024-10-24	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	68a5930b-37db-439d-8fb9-7d7de07d8465	2024-10-24	Warnings	Exact identifier application number: M012
sinus pressure pain and cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	bb0225d5-6c32-2c64-e053-2995a90a829b	2024-10-24	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148	2024-10-24	Warnings	Exact identifier application number: M012
CareOne Fast Acting Nasal	PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5	2024-10-24	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	8cb0d0c8-c565-4c5a-97c5-8250a67e23a8	2024-10-24	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	0d07a534-c67f-4041-a07c-ed7f68dfc426	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	90977b39-8ced-46bf-9d06-15306bce9b35	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2325f33-e4e4-1269-e053-2995a90ab4ac	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a8240d98-f0b0-3ded-e053-2a95a90a5cf9	2024-10-23	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a82401f5-65b1-11e9-e053-2a95a90a499e	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a823db21-4863-45a6-e053-2995a90ab8e6	2024-10-23	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2346d0c-75cf-974c-e053-2a95a90a2857	2024-10-23	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Marc Glassman, Inc.	ce573785-f77d-4314-9b7a-ef3f1f4f34d8	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a3dcc-45b4-4093-e053-2995a90a3b14	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a7cc5-bd0e-b92b-e053-2995a90af50a	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	1cd26a6a-4b50-4610-9fc8-278545d77f18	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	c5dd40e5-b4e2-4963-9a53-b71da1ed5510	2024-10-23	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