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 23 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e0d5be6-d41b-cdf8-e063-6394a90a08b4 2025-02-27 Warnings Exact identifier application number: M001 Supreme Antacid Cherry CALCIUM CARBONATE, MAGNESIUM HYDROXIDE Discount Drug Mart, Inc 2e0a1913-c3d4-7c7d-e063-6294a90a4841 2025-02-26 Warnings Exact identifier application number: M001 Extra Strength sugar free Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e09f87b-c771-59ae-e063-6294a90a0c39 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Wintergreen Flavor CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 409b5d06-3398-4414-8919-10b9064ba4ee 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2df92d5c-cd5a-060b-e063-6394a90aa51f 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2e09cb3b-cf5d-15b1-e063-6394a90a5c6a 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Smooth Assorted Fruit Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df86c35-1e9b-eb49-e063-6294a90aabb6 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Regular strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2dfa0de5-6e58-dc9d-e063-6294a90a53e0 2025-02-20 Warnings Exact identifier application number: M001 Childrens Tummy Relief CALCIUM CARBONATE Genexa Inc. f4d39d3e-82d0-2673-e053-2995a90a7d2a 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Peppermint Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df8fe2b-cc9a-f026-e063-6394a90aa0ad 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb4ce4e-e18c-c96d-e063-6394a90a18ca 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb60b7e-711a-8052-e063-6394a90acf1d 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df9e47a-8741-6958-e063-6394a90a6c60 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Discount Drug Mart, Inc 2e09b8d1-25b4-0e57-e063-6394a90a31e2 2025-02-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Orange and Cream ES CALCIUM CARBONATE Haleon US Holdings LLC 036ef1ed-32ef-46b8-8817-b3f63a014280 2025-02-14 Warnings Exact identifier application number: M001 Tums Naturals CALCIUM CARBONATE Haleon US Holdings LLC d8da54b8-6456-4e7d-acd2-a55e2249bd01 2025-02-13 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Harris Teeter, LLC 2cb4c58f-ee88-b60e-e063-6294a90a1e6c 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c4fc835-a9ad-2666-e063-6394a90a20ac 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c5081a6-367f-28bc-e063-6294a90a459e 2025-02-12 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Harris Teeter, LLC 2cb54a40-98ce-2660-e063-6294a90a3ed0 2025-02-11 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