Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime

Product NDC: 0031-8770
11-digit product format: 000318770
Labeler code: 0031
Product ID: 0031-8770_e1aff09c-8c75-45af-b83c-71be0cb7309b
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen and diphenhydramine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-15
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 Honey Severe Cough, Flu Plus Sore Throat 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
7decc168-e847-4bbe-910b-26081469406f	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0031-8770-12	2024-01-30	C162847	48780-1	1030e365-209a-111a-e063-dadaa90a10e2	7decc168-e847-4bbe-910b-26081469406f
0031-8770-18	2024-01-30	C162847	48780-1	1030e365-209a-111a-e063-dadaa90a10e2	7decc168-e847-4bbe-910b-26081469406f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0031-8770-12	Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	118 mL in 1 BOTTLE	SOLUTION	118	7
0031-8770-12	Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	1 in 1 CARTON	SOLUTION	1	7
0031-8770-18	Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	1 in 1 CARTON	SOLUTION	1	7
0031-8770-18	Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	237 mL in 1 BOTTLE	SOLUTION	237	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8770-12	ML - Milliliter	0031-8770	605767f0-4366-477a-bb33-430bd5f1beb6	1	2025-12-16
0031-8770-18	ML - Milliliter	0031-8770	02530fa9-bdd7-4319-933b-64231ea00669	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8770	ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240427_7decc168-e847-4bbe-910b-26081469406f.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 40 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb	2026-04-09	Warnings	Exact identifier application number: M012
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	e20b1093-d77f-4c39-b105-adaa1b82ea76	2026-04-09	Warnings	Exact identifier application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	4f0c1b8e-3fb1-ccf2-e063-6394a90acd15	2026-04-09	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Lidl US LLC	b26ac105-f8e4-4ad0-8a26-9fdf30c01700	2026-04-09	Warnings	Exact identifier application number: M012
Wal Dryl Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	09de28cd-fa60-4af7-b7cc-cf74c00a3531	2026-04-09	Warnings	Exact identifier application number: M012
Tussin DM Max NIGHTTIME	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	d10a413e-22a6-4799-8367-5777831756a9	2026-04-09	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	80d25e23-b108-4eb1-88c7-73fe9da8f942	2026-04-09	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR AND GUAIFENESIN	L.N.K. International, Inc.	2fea3533-8218-4875-affe-5b33a22c553a	2026-04-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Plus Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Kenvue Brands LLC	4e60e1ad-4ad4-c329-e063-6294a90ab318	2026-04-08	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4592d547-556f-4eec-8faf-6ff9a92e46c8	2026-04-08	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	e24121d2-c9d2-4bbd-869e-eeed7e2bb881	2026-04-08	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	8460d4f9-8d7b-4ae4-8047-c2010d9c8013	2026-04-08	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	d2dab450-cf82-4be2-a4e2-630295fb59ab	2026-04-08	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	4657c02b-887b-4746-8a78-83a72465e07b	2026-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	33646fab-79a5-4f10-8ac0-48423eac9b56	2026-04-07	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	76e19b9a-3bdb-479a-9503-9e8250109c84	2026-04-07	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	7959ea00-2a41-4c3c-8c58-85795ebd2afc	2026-04-06	Warnings	Exact identifier application number: M012
dimaphen dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Preferred Pharmaceuticals Inc.	da148c1d-e394-4367-83e0-533469501b30	2026-04-06	Warnings	Exact identifier application number: M012
Cough Relief Adult	DEXTROMETHORPHAN HBR	TOP CARE (Topco Associates LLC)	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	2026-04-06	Warnings	Exact identifier application number: M012
Allergy Plus Sinus Relief	DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	Rite Aid Corporation	54623e2e-5f9a-426e-8f7e-ea755ff8b3f8	2026-04-06	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	7decc168-e847-4bbe-910b-26081469406f	7
2374554	acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SCD	7decc168-e847-4bbe-910b-26081469406f	7
2374554	acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral Solution	SY	7decc168-e847-4bbe-910b-26081469406f	7
2374554	APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SY	7decc168-e847-4bbe-910b-26081469406f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8770-12	00031877012	1 BOTTLE in 1 CARTON (0031-8770-12) / 118 mL in 1 BOTTLE	1 bottle	2020-06-15	0000-00-00	No	No	Current
0031-8770-18	00031877018	1 BOTTLE in 1 CARTON (0031-8770-18) / 237 mL in 1 BOTTLE	1 bottle	2020-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
acetaminophen and diphenhydramine hydrochloride - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-04-26	HUMAN OTC DRUG LABEL	7