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 1 of 36 · 719 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Stomach Relief CALCIUM CARBONATE Wal-Mart Stores Inc 7471ec99-6c0b-40d8-a9cf-85240a0d471a 2026-09-09 Warnings Exact identifier application number: M001 Walgreens Orange Antacid Soft Chew CALCIUM CARBONATE Walgreens 5b01be31-5871-d4f5-e063-6294a90a671a 2026-09-08 Warnings Exact identifier application number: M001 Regular Strength Tropical Fruit CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 38c6cece-71a0-40d8-bfc8-2f6467f9239b 2026-09-05 Warnings Exact identifier application number: M001 Extra Strength Antacid Assorted Berries CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 07a50168-6b05-4c99-9969-7d7f0aa54f30 2026-09-05 Warnings Exact identifier application number: M001 DRx CHOICE Antacid Calcium Regular Strength CALCIUM CARBONATE 500MG Raritan Pharmaceuticals Inc 0c579405-9397-4bf2-8441-e89011b19ec4 2026-09-05 Warnings Exact identifier application number: M001 Tums Chewy Bites Wintermint and Vanilla Cream CALCIUM CARBONATE Haleon US Holdings LLC 4f094feb-8de1-4ccb-e063-6294a90acec2 2026-09-04 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE DOLGENCORP, LLC 98a0503c-add5-4453-9d9d-6f813866f4b3 2026-09-03 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE DOLGENCORP, LLC 99c7ab95-df12-4041-ae1a-398cc6f0085d 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Ultra Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Liquid Antacid plus Anti Gas CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE DOLGENCORP, LLC 8ecb4418-e647-49b5-b418-1c63bb3e5a3c 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 4942747a-8b6c-422a-8150-9bd91c0a3778 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Regular Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC 13dd2758-a372-4b0e-bc99-56a2dacbf95f 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid Wintergreen flavor CALCIUM CARBONATE DOLGENCORP, LLC b84b3509-3178-4616-9bec-dad85a4f9d2a 2026-09-03 Warnings Exact identifier application number: M001 DG Health Regular Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 59ad3cc7-4144-442f-a37d-75c5fe23e1ae 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Assorted Fruits Antacid CALCIUM CARBONATE DOLGENCORP, LLC 112f1002-c007-4363-ade6-8dfbc61f4b64 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid SMOOTH DISSOLVE CALCIUM CARBONATE DOLGENCORP, LLC cabaa8f7-9c93-439d-905a-5ef643a08ea8 2026-09-03 Warnings Exact identifier application number: M001 Kroger Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE THE KROGER CO., 175d9f0f-266a-4dc2-865f-d1ebd4ddac51 2026-09-01 Warnings Exact identifier application number: M001 Kids Antacid CALCIUM CARBONATE THE KROGER CO. d77c629b-5308-4b71-9024-9899cf88dbae 2026-09-01 Warnings Exact identifier application number: M001 Kroger Extra Strength Smooth Antacid Assorted Berry CALCIUM CARBONATE KROGER COMPANY 4c8d39d9-9d58-45df-9ffd-2cdc41539c03 2026-09-01 Warnings Exact identifier application number: M001 Kroger Ultra Strength Assorted Fruit CALCIUM CARBONATE KROGER COMPANY b60ced06-725c-4dae-abbf-21cab9e431f9 2026-08-31 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