FDA.reportPublic FDA data

Hydrocortisone

Product NDC
80489-001
11-digit product format
804890001
Labeler code
80489
Product ID
80489-001_48fe7e3f-613b-4f28-e063-6294a90aa4e0
Type
HUMAN OTC DRUG
Nonproprietary name
Drs. Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
OL PHARMA TECH,LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 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 packagepackage80489-001-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80489-001-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80489-001-01bd6a592717d7…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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal 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
b0eac8f3-bb80-6563-e053-2995a90a83c9Available 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80489-001-012023-01-17C16284748780-1d6a99b39-9b99-a426-e053-dadaa90af4c2b0eac8f3-bb80-6563-e053-2995a90a83c9
80489-001-012022-01-28C16284748780-1d6a99b39-9b99-a426-e053-dadaa90af4c2b0eac8f3-bb80-6563-e053-2995a90a83c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-001-01Hydrocortisone28.3 g in 1 TUBECREAM28.36
80489-001-01Hydrocortisone1 in 1 CARTONCREAM16
80489-001-02Hydrocortisone1 in 1 CARTONCREAM16
80489-001-02Hydrocortisone49.5 g in 1 TUBECREAM49.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-001HYDROCORTISONE (DRS. HYDROCORTISONE) CREAM [OL PHARMA TECH,LLC]5Current NDC, Legacy NDC, 4 package rows20250112_b0eac8f3-bb80-6563-e053-2995a90a83c9.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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact identifier
application number: M016
Blistex Ivarest Poison Ivy ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEBlistex Inc.e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a2024-12-11WarningsExact identifier
application number: M016
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
application number: M016
BOA VIDA Recovery CremeDIMETHICONECentral Solutions Incbfa07058-7a20-4b9f-bad1-4b9fb5c037e02024-12-09WarningsExact identifier
application number: M016
BOA VIDA CanopyDIMETHICONECentral Solutions Inc44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf2024-12-09WarningsExact identifier
application number: M016
DermaCen Skin ProtectantZINC OXIDECentral Solutions Inc990c3a65-bca5-1f0d-e053-2995a90aa7ae2024-12-09WarningsExact identifier
application number: M016
BOA VIDA CalvidaZINC OXIDECentral Solutions Inc48eb2031-bc80-45d5-b8b3-cc08fcab64f12024-12-09WarningsExact identifier
application number: M016
BOA VIDA CleansingDIMETHICONECentral Solutions Inc0b456b20-ab06-4adf-b5f0-1693d33979df2024-12-09WarningsExact identifier
application number: M016
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief TreatmentCOLLOIDAL OATMEALKenvue Brands LLCf67e528a-b822-3f7a-e053-2995a90ae7332024-12-06WarningsExact identifier
application number: M016
Humphreys MaravillaWITCH HAZELHumphreys Pharmacal, Incorporated7d403bf4-8a0d-4337-8e81-1149cd0ae1dc2024-12-06WarningsExact identifier
application number: M016
Skin Soothing CreamCOLLOIDAL OATMEALAllure Labs Inc9b1dfb4b-ce35-46a1-bfc6-ee5b871955f32024-12-05WarningsExact identifier
application number: M016
Skin Soothing Cream - Nut FreeCOLLOIDAL OATMEALAllure Labsb5eb48a5-e884-3bf6-e053-2a95a90abb972024-12-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNb0eac8f3-bb80-6563-e053-2995a90a83c96
106258hydrocortisone 10 MG/ML Topical CreamSCDb0eac8f3-bb80-6563-e053-2995a90a83c96
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb0eac8f3-bb80-6563-e053-2995a90a83c96
106258hydrocortisone 1 % Topical CreamSYb0eac8f3-bb80-6563-e053-2995a90a83c96
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb0eac8f3-bb80-6563-e053-2995a90a83c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-001-01804890001011 TUBE in 1 CARTON (80489-001-01) / 28.3 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent
80489-001-02804890001021 TUBE in 1 CARTON (80489-001-02) / 49.5 g in 1 TUBE1 tube2021-01-01NoNoCurrent