Home NDC 45802-432 pseudoephedrine hydrochloride
Product NDC 45802-432
11-digit product format 458020432
Labeler code 45802
Product ID 45802-432_c25dd71c-bfa6-45c6-a4f0-a46919acf185
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-10-17
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 pseudoephedrine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049160 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 45802-432-62 pseudoephedrine hydrochloride 24 in 1 CARTON TABLET, FILM COATED 24 7 45802-432-62 pseudoephedrine hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-432 PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 2 package rows 20240822_458594e1-8d99-4de3-8923-2fd8ce2fc406.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 45802-432-62 45802043262 24 BLISTER PACK in 1 CARTON (45802-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK 24 blister pack 2008-10-17 0000-00-00 No No Current