Home NDC 84126-353 Vicks NyQuil VapoCOOL
Product NDC 84126-353
11-digit product format 841260353
Labeler code 84126
Product ID 84126-353_5d1b00fb-b689-95aa-e063-6394a90a8554
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine Succinate, Dextromethorphan Hydrobromide
Dosage form TABLET, COATED
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-06
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 6.25; 10 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Vicks NyQuil VapoCOOL
Brand name suffix COLD and FLU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-353-02 Vicks NyQuil VapoCOOLCOLD and FLU 2 in 1 POUCH TABLET, COATED 2 6 84126-353-24 Vicks NyQuil VapoCOOLCOLD and FLU 12 in 1 CARTON TABLET, COATED 12 6 84126-353-24 Vicks NyQuil VapoCOOLCOLD and FLU 2 in 1 BLISTER PACK TABLET, COATED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84126-353 VICKS NYQUIL VAPOCOOL COLD AND FLU (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 3 Current NDC, 3 package rows 20250507_32819305-9bbd-8843-e063-6294a90a7f2e.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 74 of 180 · 3,583 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 84126-353-02 84126035302 2 TABLET, COATED in 1 POUCH (84126-353-02) 2025-05-06 No No Current 84126-353-24 84126035324 12 BLISTER PACK in 1 CARTON (84126-353-24) / 2 TABLET, COATED in 1 BLISTER PACK 12 blister pack 2025-05-06 No No Current