FDA.reportPublic FDA data

Hydrocortisone

Product NDC
61010-5800
11-digit product format
610105800
Labeler code
61010
Product ID
61010-5800_10d3fc91-82ae-e8eb-e063-6394a90ae87b
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258

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
61010-5800-22024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-02-13C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-22024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-32024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-42024-01-30C16284748780-11030e365-2764-111a-e063-dadaa90a10e261010-5800,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

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