Home NDC 51013-668 Ultra Concentrated Nighttime COLD AND FLU
Product NDC 51013-668
11-digit product format 510130668
Labeler code 51013
Product ID 51013-668_300bf27f-7450-7366-e063-6394a90acbcb
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler PuraCap Pharmaceutical LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-12
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 10; 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 2026-12-31
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 Ultra Concentrated Nighttime COLD AND FLU
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 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 1426334 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 51013-668-01 Ultra Concentrated Nighttime COLD AND FLU 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 51013-668-01 Ultra Concentrated Nighttime COLD AND FLU 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-668 ULTRA CONCENTRATED NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 Current NDC, 2 package rows 20250313_300bf27f-744f-7366-e063-6394a90acbcb.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 98 of 178 · 3,551 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 51013-668-01 51013066801 1 BLISTER PACK in 1 CARTON (51013-668-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2025-03-12 No No Current