Home NDC 69676-0093 Daytime Severe Cold and Flu
Product NDC 69676-0093
11-digit product format 696760093
Labeler code 69676
Product ID 69676-0093_2d9857c2-f02a-1a24-e063-6394a90ae1b8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form SUSPENSION
Route ORAL
Labeler Genexa Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-03
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 650; 20 mg/20mL; mg/20mL
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 Additional Listing Data#
Finished product Yes
Brand name base Daytime Severe Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 650 mg/20mL ACETAMINOPHEN 20 mg/20mL
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 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2693772 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 69676-0093-9 Daytime and Nighttime Severe Cold and Flu combo pack 177 mL in 1 BOTTLE SUSPENSION 177 mL 650 mg in 20mL 2 69676-0093-9 Daytime Severe Cold and Flu 177 mL in 1 BOTTLE SUSPENSION 177 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0093 DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SUSPENSION [GENEXA INC.] 2 Current NDC, 1 package rows 20250210_22f23aeb-f874-6e54-e063-6394a90a9565.zip 69676-0093 DAYTIME AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.] 1 Current NDC 20240927_190c7eaf-dcd4-d314-e063-6294a90a6f33.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 1 of 84 · 1,678 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 69676-0093-9 69676009309 177 mL in 1 BOTTLE (69676-0093-9) 177 ml 2024-07-03 No No Current