Home NDC 51013-666-01 Daytime COLD AND FLU
Product NDC 51013-666
Requested package NDC 51013-666-01
11-digit product format 510130666
Labeler code 51013
Product ID 51013-666_300c7b40-7df4-a3f2-e063-6394a90af47c
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
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
Active strength 325; 10 mg/1; mg/1
Pharmacologic classes 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 Daytime COLD AND FLU
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1867684 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 51013-666-01 Daytime COLD AND FLU 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 51013-666-01 Daytime COLD AND FLU 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-666 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 Current NDC, 2 package rows 20250313_300c7c7b-ea0b-3650-e063-6294a90a65e8.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 51013-666-01 51013066601 1 BLISTER PACK in 1 CARTON (51013-666-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2025-03-12 No No Current