Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime

Product NDC: 0031-0101
11-digit product format: 000310101
Labeler code: 0031
Product ID: 0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, diphenhydramine hcl
Dosage form: LIQUID
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-15
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 650; 25 mg/20mL; mg/20mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Multi-Symptom Cough Cold Flu Nighttime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL
DIPHENHYDRAMINE HYDROCHLORIDE	25 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
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2374554	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
721bfee2-0d3d-4d8b-beee-1ea83064d1c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-0101-04	Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	1 in 1 CARTON	LIQUID	1		1
0031-0101-04	Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	118 mL in 1 BOTTLE	LIQUID	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-0101	ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [HALEON US HOLDINGS LLC]	1	Current NDC, 2 package rows	20240215_721bfee2-0d3d-4d8b-beee-1ea83064d1c8.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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime Soft Chews	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2024-09-05	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	344282fc-3bd1-4f49-9bd1-08c5a58d1f73	2024-09-05	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Exact identifier application number: M012
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Exact identifier application number: M012
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Exact identifier application number: M012
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Exact identifier application number: M012
nasal mist	OXYMETAZOLINE HCL	CVS Pharmacy	b71c557a-eb93-40d1-87c4-847f5468fc1e	2024-08-28	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Kroger Company	0a24d98a-5950-49de-8b77-ea880b08d2c5	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HCL	Topco Associates LLC	b5434599-5485-4949-9d76-b1ef3ad17c1a	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f1dd78e0-f700-4469-85d6-18cc299e8746	2024-08-28	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HCL	United Natural Foods, Inc. dba UNFI	69308693-a094-42a9-a041-e73647a25cc1	2024-08-27	Warnings	Exact identifier application number: M012
signature care nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f9ac80d1-3753-412b-a407-18a6b50e5d1c	2024-08-27	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	20ac6010-84f4-eeff-e063-6294a90a50a7	2024-08-27	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
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2374554	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 20 mL Oral Solution	PSN	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	1
2374554	acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SCD	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	1
2374554	acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral Solution	SY	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	1
2374554	APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SY	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0031-0101-04	00031010104	1 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLE	1 bottle	2024-02-15	No	No	Current