FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81335-532-15UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81335-532-15UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage81335-532-15IInactivated by FDAfb8cb913e6d1…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
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106258Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b68f8ada-58e8-e8e4-e053-2a95a90ab02dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81335-532-152023-01-10C16284748780-1e4f33bdf-a4ee-d8a0-e053-dadaa90a6e4eb68f8ada-58e8-e8e4-e053-2a95a90ab02d
81335-532-152022-07-29C16284748780-1e4f33bdf-a4ee-d8a0-e053-dadaa90a6e4eb68f8ada-58e8-e8e4-e053-2a95a90ab02d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81335-532-15ZCortUltra15 g in 1 BOXCREAM156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81335-532ZCORT ULTRA (HYDROCORTISONE ACETATE 1%) CREAM [RXDINO, LLC]6Current NDC, Legacy NDC, 1 package rows20250130_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 88 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd3875bde5-2e1a-5fdf-e063-6294a90a3c0d2025-06-26WarningsExact identifier
application number: M017
SupreH Bee Venom Arthritis Pain Relieving CreamSUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3876cc44-7f3a-b084-e063-6294a90a61422025-06-26WarningsExact identifier
application number: M017
MediBalmHYDROCORTISONEBalmRx, LLC324dd151-84c5-3e2f-e063-6394a90a569d2025-06-26WarningsExact identifier
application number: M017
PHIZICO Pain ReliefMENTHOLER3 BRANDS INC.72715dc5-d1e7-4b4b-8e28-4e367abba3222025-06-25WarningsExact identifier
application number: M017
Diva Cramp Care CreamMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp37368566-b14e-4d5c-bdde-6eea9073974f2025-06-25WarningsExact identifier
application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTHLIDOCAINE HCLH2Ocean, LLC386bf11b-1d71-44bf-e063-6394a90a28172025-06-25WarningsExact identifier
application number: M017
Burn Relief Extra Strength Kool-DownLIDOCAINE - 3.9%Kool-Down Inc827fec2f-db3c-adbb-e053-2a91aa0a7c172025-06-25WarningsExact identifier
application number: M017
Hilook Blue Gel AnestheticLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9db681-a297-5aa9-e063-6394a90a80ea2025-06-25WarningsExact identifier
application number: M017
Hilook Numbing CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9f1a4c-ca0b-d820-e063-6394a90a32392025-06-25WarningsExact identifier
application number: M017
Lidocaine Knee Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd384c1ff8-80bd-86cb-e063-6394a90a2d652025-06-24WarningsExact identifier
application number: M017
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
application number: M017
NERVE REVERSE PAIN RELIEFMENTHOLPogue Medical Servicesda97bcc6-5aa8-48e2-a2c2-c937745bf6d32025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief Menthol Roll-OnMENTHOLRespect Manufacturing Corporation05a6067a-287a-52d4-e063-6394a90a2c4e2025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 500mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06c4640a-ee42-5d1a-e063-6394a90ad2542025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 1000mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06e944e8-71f6-9fe9-e063-6294a90a8c372025-06-23WarningsExact identifier
application number: M017
Procure gelMENTHOLTWIN MED, LLCe69c0b68-d408-9fd2-e053-2a95a90ac9342025-06-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNb68f8ada-58e8-e8e4-e053-2a95a90ab02d6
106258hydrocortisone 10 MG/ML Topical CreamSCDb68f8ada-58e8-e8e4-e053-2a95a90ab02d6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb68f8ada-58e8-e8e4-e053-2a95a90ab02d6
106258hydrocortisone 1 % Topical CreamSYb68f8ada-58e8-e8e4-e053-2a95a90ab02d6
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb68f8ada-58e8-e8e4-e053-2a95a90ab02d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81335-532-158133505321515 g in 1 BOX (81335-532-15) 15 g2021-03-010000-00-00NoNoCurrent