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 67 of 149 · 2,968 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MULTI-SYMPTOM COLDDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb1fae7cc-4033-44bc-aa7c-ca3ceea51c7d2025-11-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
foster and thrive 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXStrategic Sourcing Services LLC043072e5-b92d-4fed-bfd8-aea07956806b2025-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAmeriSource Bergen4a8df3c9-bed3-4371-a1c1-59afe12203e22025-11-14WarningsExact identifier
unii: 6V9V2RYJ8N
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack85b98fa3-376c-41a3-b3c1-0c739d903a222025-11-14Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: 6V9V2RYJ8N
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb2c0692c-ed0b-4fcf-b88d-59a788b124c62025-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.87ab4578-84de-475d-a4b0-eec969f172532025-11-13WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
unii: 495W7451VQ
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
unii: 495W7451VQ
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.7a78f24b-7c23-4318-99dc-90c05db185b12025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b72025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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