Home NDC 53185-277 Chlorpheniramine maleate 4mg
Product NDC 53185-277
11-digit product format 531850277
Labeler code 53185
Product ID 53185-277_3bbe161c-4342-40b5-82b6-5270ef0e31d3
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate 4mg
Dosage form TABLET, COATED
Route ORAL
Labeler Athlete's Needs, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-15
Substance CHLORPHENIRAMINE MALEATE
Active strength 4 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Chlorpheniramine maleate 4mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1363309 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 53185-277-24 Chlorpheniramine maleate 4mg 24 in 1 BOTTLE TABLET, COATED 24 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53185-277 CHLORPHENIRAMINE MALEATE 4MG TABLET, COATED [ATHLETE'S NEEDS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20231020_4d974959-25fc-4707-9b72-9afbf47b76f1.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 Marketing start Marketing end Sample Exclude flag Status 53185-277-24 53185027724 24 TABLET, COATED in 1 BOTTLE (53185-277-24) 2014-12-15 0000-00-00 No No Current