NDC 0031-8678 - Robitussin CF

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0031-8678
Package NDCs from labels: 0031-8678-82
Manufacturer: Haleon US Holdings LLC
Effective date: 2024-04-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Robitussin CF - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-04-24	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8678-82	Robitussin CF	1 in 1 CARTON	LIQUID	1		7
0031-8678-82	Robitussin CF	118 mL in 1 BOTTLE	LIQUID	118		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8678	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC]	7	2 package rows	20240426_caefc641-8470-4154-98a6-c0786071414e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN	ACTIVE INGREDIENT	7355X3ROTS	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]	1

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 66 of 149 · 2,968 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI	Family Dollar (FAMILY WELLNESS)	e5c90d6e-70aa-4886-bc81-293e0dcf5638	2025-11-24	Warnings	Exact identifier unii: 9D2RTI9KYH
Rain Daily Hydration and Comfort For Dry Eyes	GLYCERIN	Rain Eye Drops, LLC	31d7c204-fb74-fb28-e063-6294a90ab330	2025-11-23	Warnings	Exact identifier unii: PDC6A3C0OX
Childrens Multi-symptom Cold Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	1768677d-96ec-f9f7-e063-6394a90a4ef4	2025-11-21	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
MUCUS RELIEF MAX	GUAIFENESIN	Better Living Brands, LLC	8b981962-5724-47d0-81f5-945dea169943	2025-11-21	Warnings	Exact identifier unii: 495W7451VQ
childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	317ab8e0-c329-4d4e-9fd0-4bff4e1504cd	2025-11-20	Warnings	Exact identifier unii: 9D2RTI9KYH
Eyewash Additive Concentrate	WATER AND PROPYLENE GLYCOL	Haws Corporation	dd168403-398c-41ff-b1df-d93e4ff39de3	2025-11-20	Warnings	Exact identifier unii: 6DC9Q167V3 unii: 059QF0KO0R
Mucus Relief	GUAIFENESIN	AMERIFOODS TRADING COMPANY	3802d63d-7dba-50de-e063-6294a90acf7b	2025-11-20	Warnings	Exact identifier unii: 495W7451VQ
Supress DX Pediatric Drops	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	ddb95436-7806-4086-af4d-18a6625b5c83	2025-11-20	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Brain Liquescence	GINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUM	Nutritional Specialties, Inc.	a5c366f3-fd42-4602-b20b-b7b15fde564e	2025-11-19	Warnings	Exact identifier unii: PDC6A3C0OX
Hemorrhoidal Cream	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	804d7b1f-1be8-50c9-e053-2a91aa0a35d0	2025-11-18	Warnings	Exact identifier unii: PDC6A3C0OX
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	a6f750c8-8738-4965-a3ad-612c24611056	2025-11-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Sterile Water	WATER	Fresenius Kabi USA, LLC	fd823bef-c14c-4708-a18a-8aaa8470412f	2025-11-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	R J General Corporation	d786ae07-ce57-44c7-9ba5-f4c87df115de	2025-11-17	Warnings	Exact identifier unii: 9D2RTI9KYH
TYLENOL COLD AND FLU	ACETAMINPHEN	R J General Corporation	b618877b-9dbc-4ba2-be2c-bf1922c646cc	2025-11-17	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
TYLENOL SINUS SEVERE	ACETAMINOPHEN	R J General Corporation	2cbf7954-b28f-4d7b-b142-6c6c5c58b25d	2025-11-17	Warnings	Exact identifier unii: 495W7451VQ
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	R J General Corporation	8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc	2025-11-17	Warnings	Exact identifier unii: 9D2RTI9KYH
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	c5ea5a7a-c806-e5e0-e053-2995a90a15e9	2025-11-17	Warnings	Exact identifier unii: 495W7451VQ
Multi-Symptom Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	50f3157b-5788-4b63-835a-e60c8dc33df9	2025-11-17	Warnings	Exact identifier unii: 9D2RTI9KYH
Antifungal cream	ANTIFUNGAL CREAM	Guangzhou Guoyoumi Biotechnology Co Ltd	43a5b3c8-3b99-b113-e063-6394a90a9aff	2025-11-15	Warnings	Exact identifier unii: PDC6A3C0OX
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	f701a6ae-200d-48dc-94e4-6bd3228f50d4	2025-11-15	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.