Home NDC 57243-953 SU PHEDRINE PE
Product NDC 57243-953
11-digit product format 572430953
Labeler code 57243
Product ID 57243-953_b0a8247f-07de-4c82-87aa-372e91b9aa25
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Salado Sales, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-15
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 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 SU PHEDRINE PE
Brand name suffix SINUS CONGESTION
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049182 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 57243-953-44 SU PHEDRINE PESINUS CONGESTION 1 in 1 CARTON TABLET, FILM COATED 1 2 57243-953-44 SU PHEDRINE PESINUS CONGESTION 18 in 1 BLISTER PACK TABLET, FILM COATED 18 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-953 SU PHEDRINE PE SINUS CONGESTION (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 1 Current NDC, 2 package rows 20250117_ba075ff7-4e26-4856-8335-0c7dd4e198ea.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 74 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 Sample Exclude flag Status 57243-953-44 57243095344 1 BLISTER PACK in 1 CARTON (57243-953-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-01-15 No No Current