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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact 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