Home NDC 53345-056 Daytime Cold and Flu
Product NDC 53345-056
11-digit product format 533450056
Labeler code 53345
Product ID 53345-056_46995a36-4233-ddce-e063-6294a90a1b8e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Dextromethorphan hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-28
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 10; 325 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 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D 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 53345-056-01 Daytime Cold and Flu 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 53345-056-01 Daytime Cold and Flu 4000 in 1 BAG CAPSULE, LIQUID FILLED 4000 1
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 53345-056-01 53345005601 1 BAG in 1 CARTON (53345-056-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2025-12-28 No No Current