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 14 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Ultra Stregth Antacid CALCIUM CARBONATE Wal-Mart Stores, Inc. cdfe5c95-3f90-4620-a618-18bac0471c3e 2025-12-03 Warnings Exact identifier application number: M001 Walgreens Fast Acting Heartburn Relief Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE WALGREEN CO. 6eae97f3-a174-4cbc-badc-777475d2f7af 2025-11-26 Warnings Exact identifier application number: M001 Antacid Regular Strength ANTACID WALGREEN CO. ce5eef7f-497d-4c88-be6a-17eeb6e07f5b 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID WALGREEN CO. 2981c5f7-121a-4030-86b1-559061030e7a 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID CALCIUM CARBONATE WALGREEN CO. 14baa410-6ce3-4ddb-aac7-e2172d1506c4 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID WALGREEN CO. aa797e94-6560-41c9-8c71-458a1086e841 2025-11-25 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE WALGREEN COMPANY d66ec376-9cac-4de5-aac8-7c6f9aa210ce 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength Wintergreen ANTACID WALGREEN CO. ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength ANTACID WALGREEN CO. 09ef90c3-1fc3-48be-8071-2fa387a46175 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength Assorted Fruits ANTACID WALGREEN CO. 6d6cecdc-646b-4c7b-b325-9423c29c57fc 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength Assorted Fruits ANTACID WALGREEN CO. e1b55f3a-c6d7-4374-acc7-134786a3765e 2025-11-25 Warnings Exact identifier application number: M001 ULTRA STRENGTH Antacid CALCIUM CARBONATE WALGREEN CO a4dcf7b9-d2c3-45d3-9410-fc4d55052a3c 2025-11-25 Warnings Exact identifier application number: M001 FAST ACTING Heartburn Relief ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE WALGREEN CO. 48c14005-811a-4868-b33e-934845504856 2025-11-25 Warnings Exact identifier application number: M001 Walgreens Childrens Saline Laxative MAGNESIUM HYDROXIDE WALGREEN CO. 3813ed22-cf68-4c16-9b61-c39828120079 2025-11-25 Warnings Exact identifier application number: M001 Ultra Strength Assorted Berries CALCIUM CARBONATE SAM'S WEST INC bc619258-7451-460c-9472-95678ea82d6e 2025-11-20 Warnings Exact identifier application number: M001 Gelusil ALUMINA, MAGNESIA, SIMETHICONE WellSpring Pharmaceutical Corporation 92fbeec1-1562-40f3-9734-41f133d494f9 2025-11-20 Warnings Exact identifier application number: M001 GERI-MOX ANTACID ANTIGAS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE Geri-Care Pharmaceuticals, Corp 03358bc7-8819-4a05-bc13-27fbf486bd26 2025-11-20 Warnings Exact identifier application number: M001 Melox ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Belmora LLC d41f0b26-5add-4045-9754-37d70d120d28 2025-11-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Vanilla and Mint CALCIUM CARBONATE Haleon US Holdings LLC 2b9dd909-c850-3c21-e063-6394a90a15a8 2025-11-19 Warnings Exact identifier application number: M001 MAXIMUM STRENGTH ANTACID ANTIGAS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE WALGREEN COMPANY 7cd8fdf4-f762-f936-e053-2a91aa0aa6ee 2025-11-19 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