Home NDC 81335-532 ZCort
Product NDC 81335-532
11-digit product format 813350532
Labeler code 81335
Product ID 81335-532_2cddb6db-6b16-e67f-e063-6394a90a3cc6
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Acetate 1%
Dosage form CREAM
Route TOPICAL
Labeler RxDino, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-01
Substance HYDROCORTISONE ACETATE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 81335-532-15 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 81335-532-15 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 81335-532-15 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
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 ZCort
Brand name suffix Ultra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81335-532-15 ZCortUltra 15 g in 1 BOX CREAM 15 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81335-532 ZCORT ULTRA (HYDROCORTISONE ACETATE 1%) CREAM [RXDINO, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250130_b68f8ada-58e8-e8e4-e053-2a95a90ab02d.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 81335-532-15 81335053215 15 g in 1 BOX (81335-532-15) 15 g 2021-03-01 0000-00-00 No No Current