Home NDC 46122-428 Nasal Decongestant
Product NDC 46122-428
11-digit product format 461220428
Labeler code 46122
Product ID 46122-428_cfa252ca-2306-4112-a614-4fece9804f0a
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amerisource Bergen
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1981-08-25
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 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 Nasal Decongestant
Brand name suffix Maximum Strength, Non-Drowsy
Listing expiration 2027-12-31 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 46122-428-61 Nasal DecongestantMaximum Strength, Non-Drowsy 24 in 1 BLISTER PACK TABLET, FILM COATED 24 11 46122-428-61 Nasal DecongestantMaximum Strength, Non-Drowsy 4 in 1 CARTON TABLET, FILM COATED 4 11 46122-428-62 Nasal DecongestantMaximum Strength, Non-Drowsy 24 in 1 BLISTER PACK TABLET, FILM COATED 24 11 46122-428-62 Nasal DecongestantMaximum Strength, Non-Drowsy 1 in 1 CARTON TABLET, FILM COATED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-428 NASAL DECONGESTANT MAXIMUM STRENGTH, NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [AMERISOURCE BERGEN] 10 Current NDC, Legacy NDC, 4 package rows 20240816_1fdb1ba5-4072-4baf-9e30-f01d57bf6d82.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 73 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 46122-428-61 46122042861 4 BLISTER PACK in 1 CARTON (46122-428-61) / 24 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 1981-08-25 No No Current 46122-428-62 46122042862 1 BLISTER PACK in 1 CARTON (46122-428-62) / 24 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 1981-08-25 0000-00-00 No No Current