Home NDC 36800-018 TopCare
Product NDC 36800-018
11-digit product format 368000018
Labeler code 36800
Product ID 36800-018_39fb0b6e-4c31-d95c-e063-6294a90aef4d
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-10-03
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
Brand name suffix Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 203105 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 36800-018-02 TopCareHydrocortisone 28.4 g in 1 TUBE OINTMENT 28.4 4 36800-018-02 TopCareHydrocortisone 1 in 1 CARTON OINTMENT 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-018 TOPCARE HYDROCORTISONE (HYDROCORTISONE) OINTMENT [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241109_bd3585fa-3b48-49b7-8ad1-749bf1e31ed5.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 18 of 153 · 3,057 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 36800-018-02 36800001802 1 TUBE in 1 CARTON (36800-018-02) / 28.4 g in 1 TUBE 1 tube 1989-10-03 0000-00-00 No No Current