FDA.reportPublic FDA data

HYDROCORTISONE

Product NDC
59898-800
11-digit product format
598980800
Labeler code
59898
Product ID
59898-800_474ac5bb-509d-1f72-e063-6394a90aacdb
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-itch cream
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Water-Jel Technologies
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-30
Substance
HYDROCORTISONE ACETATE
Active strength
1 g/100g
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59898-800-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59898-800-03fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59898-800-36fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59898-800-32fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59898-800-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59898-800-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59898-800-0386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59898-800-3686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59898-800-3286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59898-800-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59898-800-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59898-800-03bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59898-800-36bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59898-800-32bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59898-800-02bd6a592717d7…303034d00443…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d34ae31-265a-46bc-a52d-546ea5bb24b6Available 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
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, Related label table
NDCEffectiveRelated label
59898-800-012024-02-131% Hydrocortisone Cream
59898-800-022024-02-131% Hydrocortisone Cream
59898-800-032024-02-131% Hydrocortisone Cream
59898-800-322024-02-131% Hydrocortisone Cream
59898-800-362024-02-131% Hydrocortisone Cream
59898-800-012022-01-281% Hydrocortisone Cream
59898-800-022022-01-281% Hydrocortisone Cream
59898-800-032022-01-281% Hydrocortisone Cream
59898-800-322022-01-281% Hydrocortisone Cream
59898-800-362022-01-281% Hydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-800-01HYDROCORTISONE1728 in 1 CARTONOINTMENT17287
59898-800-01HYDROCORTISONE0.9 g in 1 PACKETOINTMENT0.97
59898-800-02HYDROCORTISONE0.9 g in 1 PACKETOINTMENT0.97
59898-800-02HYDROCORTISONE144 in 1 BOX, UNIT-DOSEOINTMENT1447
59898-800-03HYDROCORTISONE25 in 1 BOX, UNIT-DOSEOINTMENT257
59898-800-03HYDROCORTISONE0.9 g in 1 PACKETOINTMENT0.97
59898-800-32HYDROCORTISONE28 g in 1 TUBEOINTMENT287
59898-800-36HYDROCORTISONE0.9 g in 1 PACKETOINTMENT0.97

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-800HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]6Current NDC, Legacy NDC, 8 package rows20240214_3d34ae31-265a-46bc-a52d-546ea5bb24b6.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 73 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017
Dollar General Menthol Pain Relief Gel RollonMENTHOLDolgencorp, LLC3a9b99e2-36b8-5dcf-e063-6394a90a382d2025-10-16WarningsExact identifier
application number: M017
Quality ChoiceHYDROCORTISONEChain Drug Marketing Association, Inc.24c3eb99-92ac-658c-e063-6394a90ab51f2025-10-16WarningsExact identifier
application number: M017
DentiCalmTOPICAL ANALGESICNFUSE LLC414e6f6f-06bb-b470-e063-6294a90af3902025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.413008cd-d239-1453-e063-6394a90a74f22025-10-15WarningsExact identifier
application number: M017
PERFORM LEO EXTENSIVE PAIN RELIEFLIDOCAINE, MENTHOLPERFORM LEO LLCf993ed5f-7dbb-4e3e-addf-f65b12f5cc482025-10-15WarningsExact identifier
application number: M017
Nufabrx Lower Leg SleeveCAPSAICINNufabrx LLCb8e3e528-b7cd-e4b7-e053-2995a90a40292025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Ankle SleeveCAPSAICINNufabrx LLC013d60c7-a613-7cdf-e063-6294a90ad5842025-10-15WarningsExact identifier
application number: M017
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
application number: M017
Nufabrx Arm SleeveCAPSAICINNufabrx LLCa7993eaf-6488-a818-e053-2995a90a7ea62025-10-15WarningsExact identifier
application number: M017
Nufabrx Back WrapCAPSAICINNufabrx LLCe4f85ac8-57cb-46eb-e053-2995a90a9b1c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC013cb66f-8695-b69f-e063-6294a90a699c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Neck WrapCAPSAICINNufabrx LLCe10b420c-500d-5738-e053-2a95a90a008f2025-10-15WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLCa5f455d4-5fc5-d516-e053-2a95a90a921e2025-10-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-800-01598980800011728 PACKET in 1 CARTON (59898-800-01) / .9 g in 1 PACKET1728 packet2010-04-300000-00-00NoNoCurrent
59898-800-0259898080002144 PACKET in 1 BOX, UNIT-DOSE (59898-800-02) / .9 g in 1 PACKET144 packet2010-04-300000-00-00NoNoCurrent
59898-800-035989808000325 PACKET in 1 BOX, UNIT-DOSE (59898-800-03) / .9 g in 1 PACKET25 packet2010-04-300000-00-00NoNoCurrent
59898-800-325989808003228 g in 1 TUBE (59898-800-32) 28 g2010-04-300000-00-00NoNoCurrent
59898-800-3659898080036.9 g in 1 PACKET (59898-800-36) 2010-04-300000-00-00NoNoCurrent