Home NDC 55289-560 Chlorpheniramine Maleate
Product NDC 55289-560
11-digit product format 552890560
Labeler code 55289
Product ID 55289-560_58b37d44-1440-96f3-e063-6394a90a45db
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-12-19
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 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 Chlorpheniramine Maleate
Listing expiration 2027-12-31 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 55289-560-01 Chlorpheniramine Maleate 100 in 1 BOTTLE, PLASTIC TABLET 100 18 55289-560-24 Chlorpheniramine Maleate 24 in 1 BOTTLE, PLASTIC TABLET 24 18 55289-560-30 Chlorpheniramine Maleate 30 in 1 BOTTLE, PLASTIC TABLET 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-560 CHLORPHENIRAMINE MALEATE TABLET [PD-RX PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 3 package rows 20250104_7a3452a2-930f-48b1-8c59-dbceb10b9c78.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 Marketing end Sample Exclude flag Status 55289-560-01 55289056001 100 TABLET in 1 BOTTLE, PLASTIC (55289-560-01) 100 tablet 2011-03-26 0000-00-00 No No Current 55289-560-24 55289056024 24 TABLET in 1 BOTTLE, PLASTIC (55289-560-24) 24 tablet 2011-03-26 0000-00-00 No No Current 55289-560-30 55289056030 30 TABLET in 1 BOTTLE, PLASTIC (55289-560-30) 30 tablet 2011-03-26 0000-00-00 No No Current