Home NDC 69423-986 Vicks NyQuil VapoCOOL Severe
Product NDC 69423-986
11-digit product format 694230986
Labeler code 69423
Product ID 69423-986_5afb0dda-8124-cbe7-e063-6394a90a6293
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide
Dosage form TABLET, COATED
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-22
Marketing end 2027-05-09
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 5; 6.25; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 Severe
Brand name suffix COLD and FLU plus CONGESTION Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1546881 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 69423-986-24 Vicks NyQuil VapoCOOL SevereCOLD and FLU plus CONGESTION 24 in 1 BLISTER PACK TABLET, COATED 24 8 69423-986-24 Vicks NyQuil VapoCOOL SevereCOLD and FLU plus CONGESTION 1 in 1 CARTON TABLET, COATED 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-986 VICKS NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 7 Current NDC, Legacy NDC, 2 package rows 20241012_efb5f0b9-9825-ab23-e053-2995a90a26ab.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 Marketing end Sample Exclude flag Status 69423-986-02 69423098602 2 TABLET, COATED in 1 POUCH (69423-986-02) 2021-03-22 0000-00-00 No No Current 69423-986-24 69423098624 1 BLISTER PACK in 1 CARTON (69423-986-24) / 24 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2021-03-22 2027-05-09 No No Current