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 24 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE Harris Teeter, LLC 2c65f7f5-195c-ed33-e063-6294a90a3070 2025-02-11 Warnings Exact identifier application number: M001 Regular Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb50083-b05f-8aca-e063-6394a90a6d6f 2025-02-11 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2c544c08-8cdb-edf2-e063-6394a90a024c 2025-02-11 Warnings Exact identifier application number: M001 Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE UNITED NATURAL FOODS, INC. DBA UNFI 1b6a28a2-f848-d185-e063-6294a90ab338 2025-02-07 Warnings Exact identifier application number: M001 Genexa Antacid Maximum Strength CALCIUM CARBONATE Genexa Inc. e4b8f068-ad52-10c8-e053-2a95a90a871f 2025-02-07 Warnings Exact identifier application number: M001 Regular Strength Peppermint Antacid CALCIUM CARBONATE DeMoulas Market Basket 89bdb1c0-df39-4c37-bb0d-0bfd0bff85fb 2025-02-07 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE UNITED NATURAL FOODS, INC. DBA UNFI 1cbea7c2-fdc0-5a6b-e063-6294a90a9cfa 2025-02-07 Warnings Exact identifier application number: M001 Regular Strength Antacid CALCIUM CARBONATE DeMoulas Market Basket be167e45-3db8-4739-91ac-e83d55223617 2025-02-07 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE UNITED NATURAL FOODS, INC. DBA UNFI 1b6a4808-4d0b-783c-e063-6394a90af0c3 2025-02-07 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Berries CALCIUM CARBONATE Guardian Drug Company 7f0ca229-7452-4f18-bd2f-bf2dfc3482f8 2025-02-06 Warnings Exact identifier application number: M001 Alkums antacid CALCIUM CARBONATE Guardian Drug Company 7451cd9f-1723-46d0-837e-8dc48bfb6bba 2025-02-06 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Retail Business Services, LLC. 1e97c054-d6b3-425a-e063-6394a90af836 2025-02-04 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Retail Business Services, LLC. 214eed56-2d35-8a69-e063-6394a90a1543 2025-02-04 Warnings Exact identifier application number: M001 Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE Harris Teeter, LLC 2bda25ff-9e56-8f8d-e063-6294a90a6a0f 2025-02-04 Warnings Exact identifier application number: M001 Extra Strength Antacid Assorted Fruit CALCIUM CARBONATE Retail Business Services, LLC. 1ea045ae-0b6a-47ae-e063-6394a90a35be 2025-02-04 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE Retail Business Services, LLC. 214eb054-b7d0-d19f-e063-6394a90a05ba 2025-02-04 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Berries CALCIUM CARBONATE Retail Business Services, LLC. 1e987226-02fa-9c10-e063-6294a90a83bf 2025-02-04 Warnings Exact identifier application number: M001 WONDERBELLY MAXIMUM STRENGTH ANTACID CALCIUM CARBONATE Ginger Health Company 2969ce5b-39ae-47b7-e063-6394a90a1909 2025-02-01 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr (650 mg) SODIUM BICARBONATE CitraGen Pharmaceuticals Inc. 650fa284-5829-588f-e053-2991aa0a9a0e 2025-01-30 Warnings Exact identifier application number: M001 Sodium Bicarbonate 5 gr (325 mg) SODIUM BICARBONATE CitraGen Pharmaceuticals Inc. 68aadbd9-f1c6-8a23-e053-2991aa0afd96 2025-01-30 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