Home NDC 0031-8716 Childrens Robitussin Cough and Cold CF
Product NDC 0031-8716
11-digit product format 000318716
Labeler code 0031
Product ID 0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-09-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Robitussin Cough and Cold CF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 50 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370205 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8716-12 Childrens Robitussin Cough and Cold CF 118 mL in 1 BOTTLE LIQUID 118 11 0031-8716-12 Childrens Robitussin Cough and Cold CF 1 in 1 CARTON LIQUID 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 PROPYLENE GLYCOL, (R)- INACTIVE INGREDIENT 602HN5L69H CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8716 CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240318_fcd0a8e0-ac2a-039a-be3c-534195d6bcfd.zip
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 17 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Strength CALCIUM CARBONATE BETTER LIVING BRANDS LLC 3ff92c9a-987f-468e-9e18-1e3e171ede14 2025-10-29 Warnings Exact identifier application number: M001 Ultra Strength CALCIUM CARBONATE BETTER LIVING BRANDS LLC 35b3d9d0-b04d-4f6d-b99d-435233803d4b 2025-10-29 Warnings Exact identifier application number: M001 Ultra Strength ANTACID TABLETS SAFEWAY 4c6cdd81-5145-4a1f-888f-85cf5d856c39 2025-10-29 Warnings Exact identifier application number: M001 Extra Strength Smooth ANTACID TABLETS SAFEWAY 8ed35c3b-9878-4889-90f7-a3973cf806e0 2025-10-29 Warnings Exact identifier application number: M001 Publix Regular Strength Assorted Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC fd637431-7a08-4454-9cae-a68716d2d0fa 2025-10-28 Warnings Exact identifier application number: M001 Publix Regular Strength Peppermint Flavor CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC c41b6cc2-c852-45fd-858c-c7bedc5dc882 2025-10-28 Warnings Exact identifier application number: M001 Publix Extra Strength Assorted Berry CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC a270fc36-f2b2-4f56-81d4-cf165f6b5abe 2025-10-28 Warnings Exact identifier application number: M001 Extra Strength Sugar Free Orange Cream Flavor CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 4dbdabc4-280d-4c9a-8c54-84afc615c8c7 2025-10-28 Warnings Exact identifier application number: M001 Publix Extra Strength Tropical Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 28e8dd03-25cf-43db-8c4d-3aae99be9d53 2025-10-28 Warnings Exact identifier application number: M001 Publix Ultra Strength Assorted Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 9e1c883f-016e-4c05-b27a-750d14c0f3e5 2025-10-28 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., 48827658-02f7-4599-a90a-1543b30b9de1 2025-10-27 Warnings Exact identifier application number: M001 Regular Strength Antacid ANTACID Wal-Mart Stores,Inc., 6e7cd170-b169-4fc0-bc90-f4421bbd9fcd 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., febe9d70-9a1f-43a9-8ad0-3134eefc6967 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., d399f927-e80b-4162-a1f1-ef6159d6f7b1 2025-10-27 Warnings Exact identifier application number: M001 equate Sugar Free Extra Strength Antacid Orange Cream Flavor ANTACID Wal-Mart Stores,Inc., 53a22b37-66af-4735-b262-15e06ad7bf76 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc. 841ddf88-a016-4a3c-9508-5d5702883d8f 2025-10-27 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Wal-Mart Stores,Inc., 6900fabc-2299-48cf-bbda-c92649cfd0e1 2025-10-27 Warnings Exact identifier application number: M001 equate Ultra Strength Antacid Peppermint Flavor ANTACID TABLETS Wal-Mart Stores,Inc., 6a18cd92-cc51-401b-9074-fbaa1afb42ac 2025-10-27 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid ANTACID TABLETS Wal-Mart Stores,Inc., 9acdfb08-043d-48a5-95f9-54bcba733c6e 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Wal-Mart Stores,Inc 448d1c72-2308-4041-8ba6-dd1e0802cc47 2025-10-27 Warnings Exact identifier application number: M001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-8716-12 00031871612 1 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLE 1 bottle 2009-09-01 0000-00-00 No No Current