Home NDC 50991-271 POLY-HIST DM
Product NDC 50991-271
11-digit product format 509910271
Labeler code 50991
Product ID 50991-271_5025c99f-b947-e2e0-e063-6394a90a13fb
Type HUMAN OTC DRUG
Nonproprietary name DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR
Dosage form LIQUID
Route ORAL
Labeler POLY PHARMACEUTICALS, INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-23
Substance DEXTROMETHORPHAN HYDROBROMIDE; DEXCHLORPHENIRAMINE MALEATE
Active strength 10; 1 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 2027-12-31
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 POLY-HIST DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL DEXCHLORPHENIRAMINE MALEATE 1 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup B10YD955QW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2741371 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 50991-271-15 POLY-HIST DM 15 mL in 1 BOTTLE LIQUID 15 1 50991-271-16 POLY-HIST DM 473 mL in 1 BOTTLE LIQUID 473 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 97 of 178 · 3,550 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 50991-271-15 50991027115 15 mL in 1 BOTTLE (50991-271-15) 15 ml 2026-04-23 No No Current 50991-271-16 50991027116 473 mL in 1 BOTTLE (50991-271-16) 473 ml 2026-04-23 No No Current