Home NDC 69423-801 Vicks NyQuil
Product NDC 69423-801
11-digit product format 694230801
Labeler code 69423
Product ID 69423-801_5d18fcce-f14a-bd94-e063-6394a90a64e7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-06
Substance DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 6.25; 325; 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
Brand name suffix ULTRA CONCENTRATED COLD and FLU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 6.25 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69423-801-48 Vicks NyQuilULTRA CONCENTRATED COLD and FLU 48 in 1 BOTTLE CAPSULE, LIQUID FILLED 48 13 69423-801-48 Vicks NyQuilULTRA CONCENTRATED COLD and FLU 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-801 VICKS NYQUIL ULTRA CONCENTRATED COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 10 Current NDC, 2 package rows 20241012_febabad6-0bf0-a3f8-e053-6294a90a3aeb.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 69423-801-48 69423080148 1 BOTTLE in 1 CARTON (69423-801-48) / 48 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2023-07-06 No No Current