FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Robitussin CF - Haleon US Holdings LLCHaleon US Holdings LLC2024-04-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8678-82Robitussin CF1 in 1 CARTONLIQUID17
0031-8678-82Robitussin CF118 mL in 1 BOTTLELIQUID1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8678ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC]72 package rows20240426_caefc641-8470-4154-98a6-c0786071414e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTSROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
GUAIFENESINACTIVE INGREDIENT495W7451VQROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
GUAIFENESINACTIVE MOIETY495W7451VQROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
SORBITOLINACTIVE INGREDIENT506T60A25RROBITUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINCE) LIQUID [RICHMOND DIVISION OF WYETH]1
WATERINACTIVE INGREDIENT059QF0KO0RROBITUSSIN 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 14 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
unii: 495W7451VQ
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
unii: 495W7451VQ
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsExact identifier
unii: 495W7451VQ
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRSelect Consumer Group55fc7d6f-cc44-b4c0-e063-6294a90ae4fc2026-07-06WarningsExact identifier
unii: 9D2RTI9KYH
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
GuaifenesinGUAIFENESINAurohealth LLC062e3d83-8495-4c8f-b1e6-5eb37fd532242026-07-03WarningsExact identifier
unii: 495W7451VQ
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
unii: 9D2RTI9KYH
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
equate mucus-erGUAIFENESINWALMART INC.a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea32026-07-02WarningsExact identifier
unii: 495W7451VQ
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
unii: 9D2RTI9KYH
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Green Guard Instydose Mucus ReliefGUAIFENESINUnifirst First Aid Corporation5b21bd13-d649-6570-e063-6394a90a51e92026-07-01WarningsExact identifier
unii: 495W7451VQ
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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