Home NDC 0113-0401 Zephrex D
Product NDC 0113-0401
11-digit product format 001130401
Labeler code 0113
Product ID 0113-0401_28086f51-f7d5-4c69-ad06-49aa164db301
Type HUMAN OTC DRUG
Nonproprietary name pseudoephedrine hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler L. Perrigo Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-04
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 Zephrex D
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1430169 Internal RxNorm lookup 1918218 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 0113-0401-62 Zephrex D 1 in 1 BLISTER PACK CAPSULE, GELATIN COATED 1 5 0113-0401-62 Zephrex D 24 in 1 CARTON CAPSULE, GELATIN COATED 24 5 0113-0401-67 Zephrex D 1 in 1 BLISTER PACK CAPSULE, GELATIN COATED 1 5 0113-0401-67 Zephrex D 48 in 1 CARTON CAPSULE, GELATIN COATED 48 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0113-0401 ZEPHREX D (PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY] 5 Current NDC, Legacy NDC, 4 package rows 20241113_5468a7e2-361b-494f-9ca3-1b62f3819f65.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 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 Marketing end Sample Exclude flag Status 0113-0401-62 00113040162 24 BLISTER PACK in 1 CARTON (0113-0401-62) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK 24 blister pack 2017-04-17 0000-00-00 No No Current 0113-0401-67 00113040167 48 BLISTER PACK in 1 CARTON (0113-0401-67) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK 48 blister pack 2017-05-08 0000-00-00 No No Current