Home NDC 0904-6728 Pseudoephedrine Hydrochloride
Product NDC 0904-6728
11-digit product format 009046728
Labeler code 0904
Product ID 0904-6728_5b76ffd1-7571-c41e-e063-6294a90a1bf3
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-26
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 60 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 Pseudoephedrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6728-46 Pseudoephedrine Hydrochloride 30 in 1 BOTTLE TABLET 30 5 0904-6728-52 Pseudoephedrine Hydrochloride 100 in 1 BOTTLE TABLET 100 5 0904-6728-52 Pseudoephedrine Hydrochloride 1 in 1 CARTON TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6728 PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 3 package rows 20240507_78fc7358-75d1-e94a-e053-2a91aa0ab0f1.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 151 of 177 · 3,534 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 0904-6728-46 00904672846 30 TABLET in 1 BOTTLE (0904-6728-46) 30 tablet 2019-08-29 0000-00-00 No No Current 0904-6728-52 00904672852 1 BOTTLE in 1 CARTON (0904-6728-52) / 100 TABLET in 1 BOTTLE 1 bottle 2019-08-26 0000-00-00 No No Current