Home NDC 65852-002 Dometuss
Product NDC 65852-002
11-digit product format 658520002
Labeler code 65852
Product ID 65852-002_3fcace53-a820-e774-e063-6294a90a32fa
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL
Dosage form LIQUID
Route ORAL
Labeler Dextrum Laboratories, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-21
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 5; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Dometuss
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1363752 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 65852-002-04 Dometuss 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 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 99 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65852-002-04 65852000204 118 mL in 1 BOTTLE, PLASTIC (65852-002-04) 118 ml 2016-01-21 No No Current