Home NDC 65852-013 Rompe Pecho CF
Product NDC 65852-013
11-digit product format 658520013
Labeler code 65852
Product ID 65852-013_401a97af-36af-4e54-e063-6294a90ab3ee
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine Maleate, Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler Dextrum Laboratories, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 4; 10 mg/5mL; mg/5mL
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Rompe Pecho CF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 4 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 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 2676758 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 65852-013-06 Rompe Pecho CF 178 mL in 1 BOTTLE, PLASTIC LIQUID 178 1 65852-013-06 Rompe Pecho CF 1 in 1 CARTON LIQUID 1 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 74 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 65852-013-06 65852001306 1 BOTTLE, PLASTIC in 1 CARTON (65852-013-06) / 178 mL in 1 BOTTLE, PLASTIC 2023-10-01 No No Current