FDA.reportPublic FDA data

Hydrocortisone Anti-Itch

Product NDC
52000-022
11-digit product format
520000022
Labeler code
52000
Product ID
52000-022_a27c1753-a558-4cf9-ba63-992d0c4cfde3
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-09
Substance
HYDROCORTISONE
Active strength
.01 g/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52000-022IInactivated by FDA2026-10-27
excluded packagepackage52000-02252000-022-37IInactivated by FDA2026-10-27

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-022-37d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-022-37f5e01cc5f278…a2eaf40c39c3…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52000-022-37e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52000-022-379bebd1f3094a…5416666fcb17…

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
Hydrocortisone Anti-Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE.01 g/g

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
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
52000-022-372025-07-29C16284748780-19d75b9cf-ed83-f424-e053-dadaa90a57ceHydrocortisone Anti-Itch Cream
52000-022-372020-12-10C16284748780-19d75b9cf-ed83-f424-e053-dadaa90a57ceHydrocortisone Anti-Itch Cream
52000-022-372020-01-31C16284748780-19d75b9cf-ed83-f424-e053-dadaa90a57ceHydrocortisone Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-022-38Hydrocortisone Anti-Itch14 g in 1 TUBECREAM144
52000-022-39Hydrocortisone Anti-Itch1 in 1 BOXCREAM14
52000-022-36Hydrocortisone Anti-Itch14 g in 1 TUBECREAM143
52000-022-37Hydrocortisone Anti-Itch1 in 1 BOXCREAM13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-022HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 2 package rows20241212_d44ee37a-305e-4adc-be42-4928d6771655.zip
52000-022HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 2 package rows20241220_186afb11-06b6-4bfa-e063-6294a90aefc6.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 79 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KNEE PAIN RELIRF PatchCAMPHOR, MENTHOLShenzhen Finona Information Technology Co., Ltd3db971ef-d7fa-0171-e063-6294a90aa58b2025-09-01WarningsExact identifier
application number: M017
Bikini Zone Medicated CremeLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC300ac57e-844a-4840-b285-41ff5518e6b62025-08-29WarningsExact identifier
application number: M017
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
application number: M017
Sumifun Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3d7dc8cc-0680-d94d-e063-6394a90ac8e82025-08-29WarningsExact identifier
application number: M017
TKTALKER NUMBINGNUMBINGShenzhen Shandian Jingling Technology Co., Ltd.3d7e6757-f183-2a68-e063-6294a90ae4ca2025-08-29WarningsExact identifier
application number: M017
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
application number: M017
else.LIDOCAINEElse Co.3d6c7b10-ed03-bbde-e063-6294a90ae92f2025-08-28WarningsExact identifier
application number: M017
Mountain Ice Pain ReliefMENTHOLMountainside Medical Equipment, Inc.c79fdd91-16f4-4ae0-bee4-d37c05ed20742025-08-28WarningsExact identifier
application number: M017
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsExact identifier
application number: M017
HealthWise Overnight Menthol PatchMENTHOLVeridian Healthcare6379f50d-2878-46ca-8acb-71c4554585e92025-08-28WarningsExact identifier
application number: M017
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.3d5718f3-c175-6b64-e063-6394a90aa6f12025-08-27WarningsExact identifier
application number: M017
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact identifier
application number: M017
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOEHYDROCORTISONEClick Industries LLC328c389c-7e05-4892-a9b3-b6a753f4935a2025-08-25WarningsExact identifier
application number: M017
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLNatures Formulae Health Products Ltd.3ce29160-3964-e435-e063-6394a90abb382025-08-21WarningsExact identifier
application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
application number: M017
Camphor 4% Plus Menthol 10%CAMPHOR 4% PLUS MENTHOL 10%PureTek Corporation3cab26e4-e377-f26a-e063-6394a90a17af2025-08-20WarningsExact identifier
application number: M017
Capsaicin 0.035% CreamCAPSAICIN 0.035% CREAMPuretekcorp3cbc73b6-8c58-8f23-e063-6394a90a71a32025-08-20WarningsExact identifier
application number: M017
Game OnMENTHOL, METHYL SALICYLATENatural Essentials, Inc.3cd20f1f-033f-f698-e063-6294a90a89eb2025-08-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN186afb11-06b6-4bfa-e063-6294a90aefc64
106258hydrocortisone 10 MG/ML Topical CreamSCD186afb11-06b6-4bfa-e063-6294a90aefc64
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY186afb11-06b6-4bfa-e063-6294a90aefc64
106258hydrocortisone 1 % Topical CreamSY186afb11-06b6-4bfa-e063-6294a90aefc64
106258hydrocortisone 1 GM per 100 GM Topical CreamSY186afb11-06b6-4bfa-e063-6294a90aefc64
106258hydrocortisone 1 % Topical CreamPSNd44ee37a-305e-4adc-be42-4928d67716553
106258hydrocortisone 10 MG/ML Topical CreamSCDd44ee37a-305e-4adc-be42-4928d67716553
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYd44ee37a-305e-4adc-be42-4928d67716553
106258hydrocortisone 1 % Topical CreamSYd44ee37a-305e-4adc-be42-4928d67716553
106258hydrocortisone 1 GM per 100 GM Topical CreamSYd44ee37a-305e-4adc-be42-4928d67716553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-022-365200000223614 g in 1 TUBE14 gHistorical
52000-022-37520000022371 TUBE in 1 BOX (52000-022-37) > 14 g in 1 TUBE (52000-022-36) 1 tube2020-12-090000-00-00NoNoCurrent
52000-022-385200000223814 g in 1 TUBE14 gHistorical
52000-022-39520000022391 TUBE in 1 BOX (52000-022-39) / 14 g in 1 TUBE (52000-022-38) 1 tube2020-12-09NoNoCurrent