Home NDC 69676-0079 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
Product NDC 69676-0079
11-digit product format 696760079
Labeler code 69676
Product ID 69676-0079_38f8afad-542e-ae0c-e063-6294a90a243f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate
Dosage form KIT
Labeler Genexa Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-31
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 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2692302 Internal RxNorm lookup 2692303 Internal RxNorm lookup 2692304 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 69676-0077-9 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 177 mL in 1 BOTTLE, PLASTIC SUSPENSION 177 mL 400 mg in 20mL 2 69676-0079-3 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 2 in 1 KIT KIT 2 2 69676-0079-3 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 1 in 1 BOTTLE KIT 1 2 69676-0094-9 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 177 mL in 1 BOTTLE SUSPENSION 177 mL 650 mg in 20mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0079 MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.] 1 Current NDC, 4 package rows 20240905_18835205-a9e3-15c2-e063-6394a90a8107.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 85 · 1,681 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 69676-0077-9 69676007709 177 mL in 1 BOTTLE, PLASTIC 177 ml Historical 69676-0079-3 69676007903 2 BOTTLE in 1 KIT (69676-0079-3) / 1 KIT in 1 BOTTLE * 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) * 177 mL in 1 BOTTLE (69676-0094-9) 2 bottle 2024-05-31 No No Current 69676-0094-9 69676009409 177 mL in 1 BOTTLE 177 ml Historical