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 129 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012
CVS Vapor Steam	CAMPHOR (SYNTHETIC)	CVS	49da2c40-afc5-5770-e054-00144ff88e88	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Daytime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Company	e428dd83-c538-2a92-e053-2a95a90a0e16	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Nighttime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Company	e46291c7-6f4d-46a2-e053-2a95a90a80a1	2024-12-13	Warnings	Exact identifier application number: M012
Foster and Thrive Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	7eaba464-5cdb-4bd4-b272-38fa108658d5	2024-12-13	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride 25mg	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Strive Pharmaceuticals Inc	b440eb2e-4de9-2b65-e053-2995a90abda8	2024-12-11	Warnings	Exact identifier application number: M012
Meijer Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	6933ca9d-a32d-d856-e053-2a91aa0a408e	2024-12-10	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	826b5c0d-7a75-bbf0-e053-2a91aa0aebd6	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	09141018-37ba-4c93-9051-1ed129c448c1	2024-12-10	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola USA Inc.	6ac9d95b-f6b9-4515-b126-697f8f839612	2024-12-10	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola USA Inc.	989d1529-2875-47bf-81df-65494d62be7a	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	82813342-2be2-4731-ae90-dbd5eed667a9	2024-12-10	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	b640a5d2-a7fe-486d-a65f-e7c993f950d6	2024-12-10	Warnings	Exact identifier application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat Drops	MENTHOL	Ricola USA Inc.	c3f3c062-55e5-43c1-a016-ee47a7b388a5	2024-12-10	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