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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General	NASAL PHENYLEPHRINE HYDROCHLORIDE	DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)	e8fd3f0e-a023-4423-8906-17ae02bc083b	2026-09-03	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	TARGET Corporation	1bf9a59e-cc37-4780-ba75-7138c546eb19	2026-09-02	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	69fd13a1-2b76-8574-e053-2a91aa0a27e7	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	a6880389-0dc1-43a7-a73b-77f77bafe51e	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	fa8510d8-d50a-4743-ba87-a12e9ab43125	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	dfcf1231-8271-458d-b375-e328d6fd4e9b	2026-09-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier application number: M012
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier application number: M012
Kroger No Drip	ALLERGY SINUS	KROGER COMPANY	4788bafb-8866-4a0a-b217-226513799c24	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Exact identifier application number: M012
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier application number: M012
MAX ALLERGY KIDS	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	96c4ade8-67b1-41e5-8624-fb49090208af	2026-09-01	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2026-08-31	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