Home NDC 85766-183 Sudafed PE Sinus Pressure Plus Pain
Product NDC 85766-183
11-digit product format 857660183
Labeler code 85766
Product ID 85766-183_4ca7a50f-d59a-2b4f-e063-6394a90ad7ad
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Phenylephrine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-10
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 5 mg/1; 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 Sudafed PE Sinus Pressure Plus Pain
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1046378 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 85766-183-24 Sudafed PE Sinus Pressure Plus Pain 2 in 1 CARTON TABLET, FILM COATED 2 1 85766-183-24 Sudafed PE Sinus Pressure Plus Pain 12 in 1 BLISTER PACK TABLET, FILM COATED 12 1
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 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 Sample Exclude flag Status 85766-183-24 85766018324 2 BLISTER PACK in 1 CARTON (85766-183-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2026-03-10 No No Current