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 6 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier unii: 495W7451VQ
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier unii: 9D2RTI9KYH
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier unii: 9D2RTI9KYH
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Rohto Preservative Free Dry Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	f4b1974c-2412-45f6-b79d-88b8a0bcb608	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
Rohto Dry-Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	8ea5c6c9-48f4-406a-a2cb-9280c546d87d	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier unii: PDC6A3C0OX
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier unii: 9D2RTI9KYH
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Sinus PE Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Better Living Brands, LLC	28a4ec37-11dd-4134-81aa-851f081bf088	2026-08-17	Warnings	Exact identifier unii: 495W7451VQ
AUVELITY	DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE	Axsome Therapeutics, Inc.	dcefda7c-9a68-278e-e053-2995a90aec79	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9D2RTI9KYH
CVS Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS HEALTH	f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6	2026-08-17	Warnings	Exact identifier unii: 9D2RTI9KYH
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	77f87e19-a9d5-479d-9434-bbde13210bfb	2026-08-15	Warnings	Exact identifier unii: 9D2RTI9KYH
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	b1c2055b-4b5a-4fa2-b600-8930c9c8524c	2026-08-15	Warnings	Exact identifier unii: 9D2RTI9KYH
Nighttime HBP Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	146c9a62-0418-4b5d-9074-5be8a05f3f93	2026-08-15	Warnings	Exact identifier unii: 9D2RTI9KYH
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Nasal Decongestant Maximum Strength, Non-Drowsy	PSEUDOEPHEDRINE HCL	Amerisource Bergen	1fdb1ba5-4072-4baf-9e30-f01d57bf6d82	2026-08-15	Warnings	Exact identifier unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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