Home NDC 0363-8100 WALGREENS
Product NDC 0363-8100
11-digit product format 003638100
Labeler code 0363
Product ID 0363-8100_44e1f405-6628-f680-e063-6294a90a4ddc
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide
Dosage form LIQUID
Route ORAL
Labeler WALGREENS CO.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 650; 20 mg/30mL; mg/30mL
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 WALGREENS
Brand name suffix Cold Cough and Flu Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D 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 2604561 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 0363-8100-12 WALGREENSCold Cough and Flu Relief 355 mL in 1 BOTTLE LIQUID 355 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-8100 WALGREENS COLD COUGH AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [WALGREENS CO.] 1 Current NDC, 1 package rows 20250418_1e903034-942e-4c6e-9f96-eb097c266580.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 73 of 178 · 3,551 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 0363-8100-12 00363810012 355 mL in 1 BOTTLE (0363-8100-12) 355 ml 2025-04-01 No No Current