Home NDC 69842-800 Nighttime Severe
Product NDC 69842-800
11-digit product format 698420800
Labeler code 69842
Product ID 69842-800_6eb654a8-b00d-4174-988d-407ee9b74361
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler CVS Pharmacy
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-06-23
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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
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 Nighttime Severe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
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 1431245 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 69842-800-40 Nighttime Severe 355 mL in 1 BOTTLE SOLUTION 355 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-800 NIGHTTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY] 5 Current NDC, Legacy NDC, 1 package rows 20241103_43784616-1afd-4ff7-8fee-6ac389f616a2.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 69842-800-40 69842080040 355 mL in 1 BOTTLE (69842-800-40) 355 ml 2016-06-23 0000-00-00 No No Current