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 131 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Aromatic CAMPHOR, MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 0e808f89-62dc-3790-e063-6394a90a2351 2024-05-13 Warnings Exact identifier application number: M017 Walgreens Lidocaine Plus Cream BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Walgreens Company e33e0097-31d6-8083-e053-2a95a90af5d2 2024-05-09 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Pain Relieving Cold Gel CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1794c512-5f42-4ec3-e063-6394a90a87cd 2024-05-03 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro MENTHOL AND CAMPHOR ACTIVE AND INNOVATIVE, LLC 17961a84-6bee-c75f-e063-6394a90af576 2024-05-03 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Pain Relieving Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd 2024-05-01 Warnings Exact identifier application number: M017 Lidocaine HCl 4 Percent LIDOCAINE HYDROCHLORIDE ARI BRANDS, LLC 81aff5c5-91c0-4173-a432-d20115613580 2024-04-30 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch 120 Bulk CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 17545078-05e1-9338-e063-6394a90a678c 2024-04-30 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Roll-on CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1755ec89-c404-1c17-e063-6394a90ab9fb 2024-04-30 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Roll On MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bc2a14-6bda-428c-e053-2995a90a4ced 2024-04-29 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Tube MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bec1d4-2e18-4519-e053-2a95a90a1bbb 2024-04-29 Warnings Exact identifier application number: M017 THERAPLEX AIM Anti-Itch Moisturizing HYDROCORTISONE THERAPLEX, LLC d1b231b6-cc9f-488a-9121-501831473772 2024-04-27 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE ACETATE JHK Inc dba American Safety & First Aid 64adc8d0-7ca4-4c1a-813f-f1df47e916f2 2024-04-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Plus Cream BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE Veridian Healthcare 16f26249-b508-2c6e-e063-6394a90a265b 2024-04-25 Warnings Exact identifier application number: M017 Hydrocortisone Cream with Aloe HYDROCORTISONE Cardinal Health 110 dba LEADER 16f2f3cb-4611-5867-e063-6394a90af107 2024-04-25 Warnings Exact identifier application number: M017 Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief MENTHOL, UNSPECIFIED FORM Walgreen Co. ede15818-5d17-477d-a8be-7b36bb0770a6 2024-04-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE Neilmed Pharmaceuticals Inc. 14b4f066-fde4-ac97-e063-6394a90ae64c 2024-04-20 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Patch MENTHOL 5% Walgreens Company e33c90d1-2729-970f-e053-2995a90ad97a 2024-04-18 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Pain Relief Patch MENTHOL Veridian Healthcare 0ce356e0-90a3-ad52-e063-6294a90a404a 2024-04-18 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