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 107 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DCH Labs Cool and Heat Roll-On MENTHOL 16% Derma Care Research Labs, LLC d35d7720-44ce-3624-e053-2995a90a7fb4 2024-12-19 Warnings Exact identifier application number: M017 Dr Goldsons Pain MENTHOL 8%, METHYL SALICYLATE 30% Derma Care Research Labs, LLC fb34b0d3-ccc0-305e-e053-6394a90a231d 2024-12-19 Warnings Exact identifier application number: M017 Warrior Pain Relieving CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30% Derma Care Research Labs, LLC dd06af3c-5452-9759-e053-2a95a90afc21 2024-12-19 Warnings Exact identifier application number: M017 Warrior Burn Relief Aloe Maximum Strength LIDOCAINE HCL 4% Derma Care Research Labs, LLC ec6efa4b-dcbe-1c2b-e053-2995a90ae043 2024-12-19 Warnings Exact identifier application number: M017 DCH Arthritis Relief TROLAMIN SALICYLATE 10% Derma Care Research Labs, LLC ff31e515-5780-b77d-e053-6394a90af6b9 2024-12-19 Warnings Exact identifier application number: M017 DCH Pain Relief LIDOCAINE 4% Derma Care Research Labs, LLC 00efda74-d434-04be-e063-6294a90a6d98 2024-12-19 Warnings Exact identifier application number: M017 Dollar General Cold Therapy Pain Relief MENTHOL 5% Dolgencorp, LLC ff3284d1-e73c-93bf-e053-6294a90aaf4e 2024-12-19 Warnings Exact identifier application number: M017 Dollar General Pain Relieving Patch with Lidocaine LIDOCAINE DOLGENCORP, LLC 55828cd1-3a1e-48ac-bb01-4c50b96d09a2 2024-12-19 Warnings Exact identifier application number: M017 DCH Nerve Pain Relief LIDOCAINE 4%, MENTHOL 1% Derma Care Research Labs, LLC 00db480a-e510-a64d-e063-6394a90a4695 2024-12-19 Warnings Exact identifier application number: M017 Pain, Burn, and Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Derma Care Research Labs, LLC fd9fe09f-3ae9-c5f5-e053-6394a90ad691 2024-12-19 Warnings Exact identifier application number: M017 DCH Cooling Pain Relief MENTHOL 4% Derma Care Research Labs, LLC 00ed3175-c3ba-6545-e063-6394a90acfd1 2024-12-19 Warnings Exact identifier application number: M017 DCH Pain Relief LIDOCAINE HCL 4% Derma Care Research Labs, LLC 00dd70f3-ecc3-33ba-e063-6294a90a4f32 2024-12-19 Warnings Exact identifier application number: M017 Walgreens Kinesiology Pain Relief LIDOCAINE, MENTHOL Walgreen Co. 0fdbb310-8e65-4e0c-b413-a093964324a2 2024-12-19 Warnings Exact identifier application number: M017 Signature Care Medicated Cold and Hot Patch MENTHOL Safeway 0335f1b3-5c8a-67b8-e063-6294a90a9847 2024-12-19 Warnings Exact identifier application number: M017 HealthWise 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 0fb2af30-7f2d-c7c4-e063-6294a90a37f7 2024-12-19 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE HCL CVS Pharmacy 445b0778-7266-4e72-97cc-e9e0d0066b61 2024-12-18 Warnings Exact identifier application number: M017 Dr. Scholls Blister Pain Relief Complete LIDOCAINE Scholl's Wellness Company LLC 26e3a678-b28f-588b-e063-6394a90ac025 2024-12-18 Warnings Exact identifier application number: M017 Dr. Scholls Blister Pain Relief Complete LIDOCAINE Scholl's Wellness Company LLC d860b339-48a0-405c-a67d-f7e7a31f6351 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Pain Relief Lidocaine LIDOCAINE Veridian Healthcare cea6cdab-28a5-5bd0-e053-2a95a90a1295 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Pain Relief Medicated LIDOCAINE AND MENTHOL Veridian Healthcare 0d092461-85fe-acf6-e063-6294a90a5aae 2024-12-18 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