Home NDC 36800-648 Topcare Nasal Four
Product NDC 36800-648
11-digit product format 368000648
Labeler code 36800
Product ID 36800-648_7d5fce56-1a65-4e69-afda-9123589511de
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-12-10
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 g/100mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Topcare Nasal Four
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL
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 1087043 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 36800-648-10 Topcare Nasal Four 1 in 1 CARTON SPRAY 1 6 36800-648-10 Topcare Nasal Four 30 mL in 1 BOTTLE, SPRAY SPRAY 30 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-648 TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241022_99bc8829-167b-4cf8-8421-57da369f24cd.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 Marketing start Marketing end Sample Exclude flag Status 36800-648-10 36800064810 1 BOTTLE, SPRAY in 1 CARTON (36800-648-10) / 30 mL in 1 BOTTLE, SPRAY 2002-12-10 0000-00-00 No No Current