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 13 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINAMERISOURCE BERGEN0269c0fd-0d8f-4264-9025-d4dcb3c45c602026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Good Neighbor Childrens Cough Relief Cherry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGENa8e2fd43-b801-41ae-8d79-8ecf4a7715432026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Good Sense Mucus DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company34f26b33-af34-470a-b57e-921fbdcbd9af2026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Good Neighbor Dye Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGEN404a3521-8340-4476-a068-0e69cd0e514f2026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsExact identifier
unii: 495W7451VQ
Good Neighbor Long Acting Cough Adult TussinDEXTROMETHORPHAN HBRAMERISOURCE BERGENdf3c76bd-bd5b-42d7-a5f1-560fd3cba6462026-07-13WarningsExact identifier
unii: 9D2RTI9KYH
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsExact identifier
unii: 495W7451VQ
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONATLANTIC BIOLOGICALS CORP.3983d6d3-8bf4-4a88-962f-9bf72fd6e6852026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Severe Congestion and Cough Multi-Symptom Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy707eb066-cdfc-444b-833a-9d6d133d48e42026-07-10WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
unii: 495W7451VQ
RUGBY ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories35f93439-eed1-40f4-a792-7527fbf3c19a2026-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATESun Pharmaceutical Industries, Inc.92b54ac4-594e-47b8-a4d3-394a29b425f32026-07-08Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
unii: 9D2RTI9KYH
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
unii: 9D2RTI9KYH
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
unii: 9D2RTI9KYH
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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