Home NDC 55301-753 Suphedrine PE Sinus Congestion
Product NDC 55301-753
11-digit product format 553010753
Labeler code 55301
Product ID 55301-753_a4ecd674-9694-4739-80ae-a3255595ec6d
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-15
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 Suphedrine PE Sinus Congestion
Brand name suffix Non-Drowsy
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 55301-753-23 Suphedrine PE Sinus CongestionNon-Drowsy 3 in 1 CARTON TABLET, FILM COATED 3 7 55301-753-23 Suphedrine PE Sinus CongestionNon-Drowsy 24 in 1 BLISTER PACK TABLET, FILM COATED 24 7 55301-753-44 Suphedrine PE Sinus CongestionNon-Drowsy 1 in 1 CARTON TABLET, FILM COATED 1 7 55301-753-44 Suphedrine PE Sinus CongestionNon-Drowsy 18 in 1 BLISTER PACK TABLET, FILM COATED 18 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-753 SUPHEDRINE PE SINUS CONGESTION NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE] 6 Current NDC, Legacy NDC, 4 package rows 20250130_b9122fd0-0bed-4302-9bbe-cd6a46d29818.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 55301-753-23 55301075323 3 BLISTER PACK in 1 CARTON (55301-753-23) / 24 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2021-01-15 0000-00-00 No No Current 55301-753-44 55301075344 1 BLISTER PACK in 1 CARTON (55301-753-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2021-01-15 0000-00-00 No No Current