Home NDC 81522-899 Night Time Cold and Flu Relief
Product NDC 81522-899
11-digit product format 815220899
Labeler code 81522
Product ID 81522-899_9c107676-24f0-4cdd-aa45-87cde3359ef8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler FSA Store Inc. (Caring Mills)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-25
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 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 Night Time Cold and Flu Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 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 81522-899-16 Night Time Cold and Flu Relief 16 in 1 CARTON CAPSULE, LIQUID FILLED 16 5 81522-899-16 Night Time Cold and Flu Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-899 NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FSA STORE INC. (CARING MILLS)] 4 Current NDC, Legacy NDC, 2 package rows 20240612_a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff.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 81522-899-16 81522089916 16 BLISTER PACK in 1 CARTON (81522-899-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 16 blister pack 2022-11-25 0000-00-00 No No Current