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 3 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Kroger Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	c5ce0901-a5d7-46c4-8492-5a80c76e8517	2026-09-02	Warnings	Exact identifier unii: 9D2RTI9KYH
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Leader Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	7c54d128-9da7-49d7-bda4-9d4f7b8bc652	2026-09-01	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN CO.	4daddd32-615f-aedf-e063-6394a90a5b09	2026-09-01	Warnings	Exact identifier unii: 6V9V2RYJ8N
Dextromethorphan HBr	DEXTROMETHORPHAN HBR	BIONPHARMA INC.	5a5dde85-8785-8149-e063-6294a90a4d57	2026-08-31	Warnings	Exact identifier unii: 9D2RTI9KYH
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF	DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL	Reckitt Benckiser LLC	8d670d91-9e22-45b9-b568-5b62c2133d32	2026-08-31	Warnings	Exact identifier unii: 9D2RTI9KYH
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier unii: 9D2RTI9KYH
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier unii: 9D2RTI9KYH
MAX Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	Akron Pharma Inc.	3b023b91-e703-4599-9864-96d8c328b45c	2026-08-31	Warnings	Exact identifier unii: 495W7451VQ
MAX Tussin Mucus and Chest Congestion	GUAIFENESIN	Akron Pharma Inc.	ac874a31-5556-4669-937f-dcb52aaecd8a	2026-08-31	Warnings	Exact identifier unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	e0ce4287-bfa1-4413-97c8-4fe2e39bda36	2026-08-31	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Select Consumer Group	3c9c8fb0-8a00-4b0f-e063-6394a90af632	2026-08-30	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Tussin DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	432d4833-2eaf-4f7c-b6b4-41043a6b7e2a	2026-08-28	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum Strength Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Wal-Mart Stores, Inc.	ff7280e7-804b-423d-add8-54ec2c76fca2	2026-08-28	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	d8a693f7-03c1-4583-89a8-8d506a894b24	2026-08-28	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Hyvee Inc	4e578c7a-88d4-e4cd-e063-6394a90aac44	2026-08-27	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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