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 126 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join equaline anti itch HYDROCORTISONE United Natural Foods, Inc. dba UNFI 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 2024-09-24 Warnings Exact identifier application number: M017 good sense itch relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE L. Perrigo Company 162fe0a3-3995-4e6f-94ed-f839b2b0c80e 2024-09-24 Warnings Exact identifier application number: M017 Caring Mill Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Veridian Healthcare 22ca137a-576c-a13c-e063-6394a90ae7fc 2024-09-23 Warnings Exact identifier application number: M017 Signature Care Anti Itch HYDROCORTISONE Safeway ed0eb068-3ce6-423d-a7f8-c3456b7f6040 2024-09-23 Warnings Exact identifier application number: M017 members mark hydrocortisone HYDROCORTISONE Sam's West Inc 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 2024-09-23 Warnings Exact identifier application number: M017 anti itch HYDROCORTISONE Meijer, Inc. a07496e0-6fc2-4190-8a01-f513134ffb92 2024-09-23 Warnings Exact identifier application number: M017 ZYLOTROL PAIN RELIEVING LIDOCAINE HCL, MENTHOL Whitestone Products LLC 2301fed7-0fa9-450d-8b1b-006f53235be0 2024-09-21 Warnings Exact identifier application number: M017 Tibetree Cheezheng Joint Analgesic Patch CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 65a8a63f-1864-473e-be72-7840a6a5dee7 2024-09-20 Warnings Exact identifier application number: M017 Cold Ice Analgesic Gel MENTHOL Dabur India Limited 22915b2f-5f76-3e38-e063-6394a90a07b4 2024-09-20 Warnings Exact identifier application number: M017 Exchange Select Hydrocortisone HYDROCORTISONE Army & Air Force Exchange Service 1b709db3-7dc1-4756-a8a0-dddda875dc57 2024-09-19 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc e1a8d4a7-01f7-4bab-8d09-875c461b3b61 2024-09-19 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Strategic Sourcing Services, LLC 2216d799-7f6f-cab7-e063-6294a90a8d6c 2024-09-14 Warnings Exact identifier application number: M017 Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Exact identifier application number: M017 leader anti itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Cardinal Health 110, LLC. dba Leader e1aab35b-80d9-4515-afb7-8c662bc5d028 2024-09-11 Warnings Exact identifier application number: M017 LactiGo MENTHOL LactiGo, Inc. 849c3601-2bc8-0991-e053-2a91aa0a5e7f 2024-09-03 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis MENTHOL 8% Telebrands Corp c22cf1a5-0d5d-5ea5-e053-2995a90a333b 2024-09-02 Warnings Exact identifier application number: M017 Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017
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