Home NDC 57243-453 SU PHEDRINE PE
Product NDC 57243-453
11-digit product format 572430453
Labeler code 57243
Product ID 57243-453_5ae58203-4d1e-42ed-bbbe-e27aca71dc91
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 2005-01-14
Marketing end 2026-11-30
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 Non-Drowsy, Maximum Strength 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 57243-453-44 SU PHEDRINE PENon-Drowsy, Maximum Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 57243-453-44 SU PHEDRINE PENon-Drowsy, Maximum Strength 18 in 1 BLISTER PACK TABLET, FILM COATED 18 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-453 SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20250117_9056fa58-d6aa-4df5-97e0-9be3f2332f86.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 Marketing end Sample Exclude flag Status 57243-453-44 57243045344 1 BLISTER PACK in 1 CARTON (57243-453-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2005-01-14 2026-11-30 No No Current