FDA.reportPublic FDA data

KERA HC

Product NDC
44577-623
11-digit product format
445770623
Labeler code
44577
Product ID
44577-623_09d72089-c2ef-70f3-e063-6394a90a65ad
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROCORTISONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-17
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
KERA HC
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106258Internal RxNorm lookup
1314932Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac215c8f-b224-480c-9295-3a34316293baAvailable 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
44577-623-02KERA HC56 g in 1 TUBECREAM564

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
UREAINACTIVE INGREDIENT8W8T17847WKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RKERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-623KERA HC (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231111_ac215c8f-b224-480c-9295-3a34316293ba.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 8 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Barmicil PlusHYDROCORTISONEOPMX LLC5763b4de-06f2-7b19-e063-6294a90ad0682026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNac215c8f-b224-480c-9295-3a34316293ba4
1314932Kera-HC 1 % Topical CreamPSNac215c8f-b224-480c-9295-3a34316293ba4
1314932hydrocortisone 10 MG/ML Topical Cream [Kera-HC]SBDac215c8f-b224-480c-9295-3a34316293ba4
106258hydrocortisone 10 MG/ML Topical CreamSCDac215c8f-b224-480c-9295-3a34316293ba4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYac215c8f-b224-480c-9295-3a34316293ba4
106258hydrocortisone 1 % Topical CreamSYac215c8f-b224-480c-9295-3a34316293ba4
106258hydrocortisone 1 GM per 100 GM Topical CreamSYac215c8f-b224-480c-9295-3a34316293ba4
1314932Kera-HC 1 % Topical CreamSYac215c8f-b224-480c-9295-3a34316293ba4
1314932Kera-HC 10 MG/ML Topical CreamSYac215c8f-b224-480c-9295-3a34316293ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-623-024457706230256 g in 1 TUBE (44577-623-02) 56 g2017-02-060000-00-00NoNoCurrent