Home NDC 36800-704 PE Sinus Congestion
Product NDC 36800-704
11-digit product format 368000704
Labeler code 36800
Product ID 36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-15
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 PE 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 36800-704-07 PE Sinus Congestion 2 in 1 CARTON TABLET, FILM COATED 2 6 36800-704-07 PE Sinus Congestion 18 in 1 BLISTER PACK TABLET, FILM COATED 18 6 36800-704-29 PE Sinus Congestion 150 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 150 6 36800-704-29 PE Sinus Congestion 1 in 1 CARTON TABLET, FILM COATED 1 6 36800-704-44 PE Sinus Congestion 1 in 1 CARTON TABLET, FILM COATED 1 6 36800-704-44 PE Sinus Congestion 18 in 1 BLISTER PACK TABLET, FILM COATED 18 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-704 PE SINUS CONGESTION (PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC] 5 Current NDC, Legacy NDC, 6 package rows 20250130_3264e291-7a0f-4e25-8390-ba441f22f650.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 36800-704-07 36800070407 2 BLISTER PACK in 1 CARTON (36800-704-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2022-03-15 0000-00-00 No No Current 36800-704-29 36800070429 1 BOTTLE, PLASTIC in 1 CARTON (36800-704-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2022-03-15 0000-00-00 No No Current 36800-704-44 36800070444 1 BLISTER PACK in 1 CARTON (36800-704-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2022-03-15 0000-00-00 No No Current