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 18 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Smooth Antacid ANTACID TABLETS Wal-Mart Stores,Inc., 92372491-000d-4273-a668-b87722c1d381 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Smooth Antacid Assorted Berries ANTACID TABLETS Wal-Mart Stores,Inc., cc93e3b4-adbc-4a2c-b6fc-bf7456ef1656 2025-10-27 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Kesin Pharma 31f417f0-1637-eefa-e063-6294a90a121b 2025-10-27 Warnings Exact identifier application number: M001 Rugby Extra Strength Assorted Berries ANTACID TABLETS Rugby Laboratories b0fcfd66-276e-4741-9aee-915b6364f25c 2025-10-25 Warnings Exact identifier application number: M001 Rugby ANTACID TABLETS Rugby Laboratories 9cb56bc3-7075-4f81-bd10-7e602034b7d8 2025-10-25 Warnings Exact identifier application number: M001 Rugby Cal-Gest Antacid Assorted Flavors ANTACID TABLETS Rugby Laboratories, Inc. a43184c4-d225-4539-b651-4d96535f208f 2025-10-25 Warnings Exact identifier application number: M001 Super vitamin C serum SUPER VITAMIN C FlexiGo Inc 41cbe84e-3ddf-b806-e063-6294a90a55a4 2025-10-22 Warnings Exact identifier application number: M001 Exchange Select Antacid Soft Chews Cherry Flavor CALCIUM CARBONATE Army & Air Force Exchange Service 41ad5581-5b8a-1c8b-e063-6294a90a2ba6 2025-10-21 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Method Pharmaceuticals, LLC 0af63651-f9d9-43b9-b6f0-4878466a82e6 2025-10-21 Warnings Exact identifier application number: M001 CardinalExtra Strength Antacid Wintergreen flavor CALCIUM CARBONATE CARDINAL HEALTH 4e40989f-c710-442a-bb8d-02e813ddf04d 2025-10-14 Warnings Exact identifier application number: M001 Regular Strength Antacid Assorted Fruit CALCIUM CARBONATE CARDINAL HEALTH def9eaef-308f-49f2-898b-469c2c395d27 2025-10-14 Warnings Exact identifier application number: M001 Leader Extra Strength Sugar Free Antacid ANTACID Cardinal Health d7a6f1b8-bdf7-45bb-bab0-b22f45e78440 2025-10-14 Warnings Exact identifier application number: M001 Extra Strength Antacid Original Flavor ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Cardinal Health 1fe459f6-be7f-4c59-b33b-f13ec17071f2 2025-10-14 Warnings Exact identifier application number: M001 Cardinal Extra Strength Smooth Antacid Assorted Fruits CALCIUM CARBONATE CARDINAL HEALTH 84bf7fea-a071-4583-9453-1aea4d198ca6 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE Cardinal Health 110, LLC. 3ce9b97b-1680-4299-9a2c-132318adbc0c 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. 7c1b2ee6-b691-4c12-bed5-f0a360ad46bb 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Ultra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. d267ca31-09bd-46d3-be08-a259642f1b7f 2025-10-14 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE A-S Medication Solutions c14d2b4d-d6d8-4293-835e-5d893d5b7e6a 2025-10-10 Warnings Exact identifier application number: M001 Calcium Carbonate Antacid Assorted Berries CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 3f640ccd-4b8d-fc24-e063-6294a90a6e58 2025-09-22 Warnings Exact identifier application number: M001 Stomachin Antacid MAGNESIUM CARBONATE AND SODIUM BICARBONATE Chang Kuo Chou Pharmaceutical Co., Ltd. 60fa0650-8785-4cb3-8f88-1a437296252f 2025-09-19 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