FDA.reportPublic FDA data

hydrocortisone

Product NDC
45802-438
Requested package NDC
45802-438-05
11-digit product format
458020438
Labeler code
45802
Product ID
45802-438_adca01b2-b9fa-4785-be0e-1bd493446cc7
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-06
Substance
HYDROCORTISONE
Active strength
1 g/100g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45802-43845802-438-05DDiscontinued by firm2026-10-27

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
HYDROCORTISONE1 g/100g

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
2dc7f76f-f9ad-46ba-8b41-952e1c15f052Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-438-03hydrocortisone28 g in 1 TUBECREAM289
45802-438-03hydrocortisone1 in 1 CARTONCREAM19
45802-438-05hydrocortisone454 g in 1 JARCREAM4549
45802-438-70hydrocortisone144 in 1 CARTONCREAM1449
45802-438-70hydrocortisone.9 g in 1 PACKETCREAM.99

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-438-03GM - Gram45802-4383634198b-3abd-46dd-9e1a-f43c8f37ad4512012-07-24
45802-438-05GM - Gram45802-438e7af108f-440a-4ff7-94c2-15cb34cf5cea12012-07-24
45802-438-70EA - Each45802-4383d62d85d-e8af-4abb-8dee-b614f448fd9e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [PERRIGO NEW YORK INC]2
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-438HYDROCORTISONE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 5 package rows20241011_2dc7f76f-f9ad-46ba-8b41-952e1c15f052.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 56 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact identifier
application number: M017
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
application number: M017
LidaFlexLIDOCAINESOLA Pharmaceuticalsb9e49529-13b4-1b0b-e053-2995a90adc7a2025-12-08WarningsExact identifier
application number: M017
Rugby Menthol Hot Cold PatchMENTHOLRUGBY LABORATORIESc68d29c2-9b56-4994-e053-2a95a90ae60e2025-12-08WarningsExact identifier
application number: M017
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN2dc7f76f-f9ad-46ba-8b41-952e1c15f0529
106258hydrocortisone 10 MG/ML Topical CreamSCD2dc7f76f-f9ad-46ba-8b41-952e1c15f0529
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2dc7f76f-f9ad-46ba-8b41-952e1c15f0529
106258hydrocortisone 1 % Topical CreamSY2dc7f76f-f9ad-46ba-8b41-952e1c15f0529
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2dc7f76f-f9ad-46ba-8b41-952e1c15f0529
106258hydrocortisone 1 % Topical CreamPSN12cd35e3-e707-4551-b778-bf615c1a8d326
106258hydrocortisone 1 % Topical CreamPSNa0fde5c9-afb2-76a9-e053-2995a90af3e86
106258hydrocortisone 10 MG/ML Topical CreamSCD12cd35e3-e707-4551-b778-bf615c1a8d326
106258hydrocortisone 10 MG/ML Topical CreamSCDa0fde5c9-afb2-76a9-e053-2995a90af3e86
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYa0fde5c9-afb2-76a9-e053-2995a90af3e86
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY12cd35e3-e707-4551-b778-bf615c1a8d326
106258hydrocortisone 1 % Topical CreamSYa0fde5c9-afb2-76a9-e053-2995a90af3e86
106258hydrocortisone 1 % Topical CreamSY12cd35e3-e707-4551-b778-bf615c1a8d326
106258hydrocortisone 1 GM per 100 GM Topical CreamSYa0fde5c9-afb2-76a9-e053-2995a90af3e86
106258hydrocortisone 1 GM per 100 GM Topical CreamSY12cd35e3-e707-4551-b778-bf615c1a8d326
106258hydrocortisone 1 % Topical CreamPSNb6734f71-dcbc-49ac-9c13-455ed624d08f5
106258hydrocortisone 10 MG/ML Topical CreamSCDb6734f71-dcbc-49ac-9c13-455ed624d08f5
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb6734f71-dcbc-49ac-9c13-455ed624d08f5
106258hydrocortisone 1 % Topical CreamSYb6734f71-dcbc-49ac-9c13-455ed624d08f5
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb6734f71-dcbc-49ac-9c13-455ed624d08f5
106258hydrocortisone 1 % Topical CreamPSN484fe5e4-a058-49c0-a382-c8fc3e20c3b23
106258hydrocortisone 1 % Topical CreamPSN47e9fe84-bd0c-40ea-85de-e950bcacc5573
106258hydrocortisone 10 MG/ML Topical CreamSCD484fe5e4-a058-49c0-a382-c8fc3e20c3b23
106258hydrocortisone 10 MG/ML Topical CreamSCD47e9fe84-bd0c-40ea-85de-e950bcacc5573
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY47e9fe84-bd0c-40ea-85de-e950bcacc5573
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY484fe5e4-a058-49c0-a382-c8fc3e20c3b23
106258hydrocortisone 1 % Topical CreamSY484fe5e4-a058-49c0-a382-c8fc3e20c3b23
106258hydrocortisone 1 % Topical CreamSY47e9fe84-bd0c-40ea-85de-e950bcacc5573
106258hydrocortisone 1 GM per 100 GM Topical CreamSY484fe5e4-a058-49c0-a382-c8fc3e20c3b23
106258hydrocortisone 1 GM per 100 GM Topical CreamSY47e9fe84-bd0c-40ea-85de-e950bcacc5573
106258hydrocortisone 1 % Topical CreamPSN96a2d2c6-cc01-4df3-a572-fff39334d91e1
106258hydrocortisone 1 % Topical CreamPSN9c0feade-bb3f-4251-b8ae-aee4f548238f1
106258hydrocortisone 1 % Topical CreamPSN20b3934b-edc4-40b8-b5fa-17259a200c5d1
106258hydrocortisone 1 % Topical CreamPSNee64ad1e-78db-4553-a3cf-b539b770fa261
106258hydrocortisone 10 MG/ML Topical CreamSCD96a2d2c6-cc01-4df3-a572-fff39334d91e1
106258hydrocortisone 10 MG/ML Topical CreamSCD9c0feade-bb3f-4251-b8ae-aee4f548238f1
106258hydrocortisone 10 MG/ML Topical CreamSCDee64ad1e-78db-4553-a3cf-b539b770fa261
106258hydrocortisone 10 MG/ML Topical CreamSCD20b3934b-edc4-40b8-b5fa-17259a200c5d1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY96a2d2c6-cc01-4df3-a572-fff39334d91e1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYee64ad1e-78db-4553-a3cf-b539b770fa261
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY9c0feade-bb3f-4251-b8ae-aee4f548238f1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY20b3934b-edc4-40b8-b5fa-17259a200c5d1
106258hydrocortisone 1 % Topical CreamSY9c0feade-bb3f-4251-b8ae-aee4f548238f1
106258hydrocortisone 1 % Topical CreamSY96a2d2c6-cc01-4df3-a572-fff39334d91e1
106258hydrocortisone 1 % Topical CreamSY20b3934b-edc4-40b8-b5fa-17259a200c5d1
106258hydrocortisone 1 % Topical CreamSYee64ad1e-78db-4553-a3cf-b539b770fa261
106258hydrocortisone 1 GM per 100 GM Topical CreamSY9c0feade-bb3f-4251-b8ae-aee4f548238f1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY96a2d2c6-cc01-4df3-a572-fff39334d91e1
106258hydrocortisone 1 GM per 100 GM Topical CreamSYee64ad1e-78db-4553-a3cf-b539b770fa261
106258hydrocortisone 1 GM per 100 GM Topical CreamSY20b3934b-edc4-40b8-b5fa-17259a200c5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-438-05458020438051 JAR in 1 CARTON (45802-438-05) > 454 g in 1 JAR1 jar2011-05-100000-00-00NoNoCurrent