Home NDC 65852-012 Giltuss Cough and Cold
Product NDC 65852-012
11-digit product format 658520012
Labeler code 65852
Product ID 65852-012_3f12ee8f-d1c7-d73a-e063-6394a90a9199
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Dextrum Laboratories Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-10-02
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength 15; 10; 300 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 Giltuss Cough and Cold
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL GUAIFENESIN 300 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 04JA59TNSJ Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65852-012-04 Giltuss Cough and Cold 1 in 1 CARTON SOLUTION 1 1 65852-012-04 Giltuss Cough and Cold 113 mL in 1 BOTTLE, PLASTIC SOLUTION 113 1
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 123 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65852-012-04 65852001204 1 BOTTLE, PLASTIC in 1 CARTON (65852-012-04) / 113 mL in 1 BOTTLE, PLASTIC 2018-10-02 No No Current