Home NDC 72789-134 Chlorpheniramine Maleate 4 mg
Product NDC 72789-134
11-digit product format 727890134
Labeler code 72789
Product ID 72789-134_e66068ef-bd74-28c5-e053-2995a90ad16e
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72789-134-24 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72789-134-24 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-134 CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET [PD-RX PHARMACEUTICALS, INC.] 9 Legacy NDC 20241010_3b7e7a3f-b768-4bb7-b4c1-a5eaed16d236.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72789-134-24 72789013424 24 TABLET in 1 BOTTLE, PLASTIC (72789-134-24) 24 tablet 2021-03-26 0000-00-00 No No Current