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 80 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	d0dd4a75-da65-4c66-b65f-54ee14100846	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care Cherry Cough Drops	MENTHOL	Amazon.com	c0588221-0c84-66d8-e053-2995a90a874f	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care Honey Lemon Cough Drops	MENTHOL	Amazon.com	c0937b13-f679-a764-e053-2a95a90abf89	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Menthol Cough Drops	MENTHOL	Amazon.com	c0946295-7cf0-1bd8-e053-2a95a90af5af	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care SF Honey Lemon Cough Drops	MENTHOL	Amazon.com	cf82fb0b-1b4d-def1-e053-2995a90a6fd9	2025-12-05	Warnings	Exact identifier application number: M012
G-DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	2025-12-05	Warnings	Exact identifier application number: M012
Quality Choice Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	Chain Drug Manufacturing Assn	ce658dd5-b683-436e-b16b-0c06f6f87fd9	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a87ba15f-b5a9-4983-a721-ca7f705aea86	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a12e2e66-d2f3-47a6-a915-a309ae828d27	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Chest Congestion	GUAIFENESIN	Chain Drug Manufacturing Assn	034d39c0-9aad-4dff-a158-a041b9f0504f	2025-12-04	Warnings	Exact identifier application number: M012
Quality Choice	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d01b8fb6-1ddf-4901-bda6-ae608e94a6a4	2025-12-04	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Manufacturing Assn	06822a28-3f82-471d-8db5-c5981b263a03	2025-12-04	Warnings	Exact identifier application number: M012
QUALITY CHOICE	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	14596551-dd82-46b3-8eb8-e69efaea105b	2025-12-04	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	fd5c20ed-5520-4db0-bfd4-995f043af2a4	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	89c165ba-3ad5-49b5-a5bb-423dc8e15bad	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a2b30c27-b836-f09f-e053-2995a90ac383	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	a37c9d9d-52db-23ff-e053-2995a90a8f76	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a68df74d-dd26-3ae9-e053-2995a90a08d6	2025-12-04	Warnings	Exact identifier application number: M012
Circle K Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	55662ada-677e-4048-9529-5bca44076316	2025-12-04	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