FDA.reportPublic FDA data

Hydrocortisone

Product NDC
61010-5800
11-digit product format
610105800
Labeler code
61010
Product ID
61010-5800_58f3ba80-d594-c121-e063-6294a90a5e2e
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-15
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

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
da2b3b2c-11e0-401b-bbd2-d019271d1b3dAvailable 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
61010-5800-22024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-02-1361010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-01-3061010-5800,Safetec First Aid 1% Hydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5800-1Hydrocortisone0.9 g in 1 POUCHCREAM0.95
61010-5800-2Hydrocortisone144 in 1 BOXCREAM1445
61010-5800-3Hydrocortisone25 in 1 BOXCREAM255
61010-5800-4Hydrocortisone10 in 1 BOXCREAM105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
PEG-150 distearateINACTIVE INGREDIENT6F36Q0I0ACHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
steareth-20INACTIVE INGREDIENTL0Q8IK9E08HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5800HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]5Current NDC, Legacy NDC, 4 package rows20240214_da2b3b2c-11e0-401b-bbd2-d019271d1b3d.zip
61010-5800CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNda2b3b2c-11e0-401b-bbd2-d019271d1b3d5
106258hydrocortisone 10 MG/ML Topical CreamSCDda2b3b2c-11e0-401b-bbd2-d019271d1b3d5
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYda2b3b2c-11e0-401b-bbd2-d019271d1b3d5
106258hydrocortisone 1 % Topical CreamSYda2b3b2c-11e0-401b-bbd2-d019271d1b3d5
106258hydrocortisone 1 GM per 100 GM Topical CreamSYda2b3b2c-11e0-401b-bbd2-d019271d1b3d5
106258hydrocortisone 1 % Topical CreamPSNfabcaa3b-d189-bd29-e053-6294a90ae86b2
106258hydrocortisone 10 MG/ML Topical CreamSCDfabcaa3b-d189-bd29-e053-6294a90ae86b2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYfabcaa3b-d189-bd29-e053-6294a90ae86b2
106258hydrocortisone 1 % Topical CreamSYfabcaa3b-d189-bd29-e053-6294a90ae86b2
106258hydrocortisone 1 GM per 100 GM Topical CreamSYfabcaa3b-d189-bd29-e053-6294a90ae86b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5800-1610105800010.9 g in 1 POUCH0.9 gHistorical
61010-5800-261010580002144 POUCH in 1 BOX (61010-5800-2) / .9 g in 1 POUCH (61010-5800-1) 144 pouch2010-12-150000-00-00NoNoCurrent
61010-5800-36101058000325 POUCH in 1 BOX (61010-5800-3) / .9 g in 1 POUCH (61010-5800-1) 25 pouch2010-12-150000-00-00NoNoCurrent
61010-5800-46101058000410 POUCH in 1 BOX (61010-5800-4) / .9 g in 1 POUCH (61010-5800-1) 10 pouch2020-04-010000-00-00NoNoCurrent