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
Ingredient	Strength
HYDROCORTISONE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ac215c8f-b224-480c-9295-3a34316293ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44577-623-02	KERA HC	56 g in 1 TUBE	CREAM	56		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KERA HC HYDROCORTISONE (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44577-623	KERA HC (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	4	Current NDC, Legacy NDC, 1 package rows	20231111_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 127 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUGBY HYDROCORTISONE WITH ALOE	HYDROCORTISONE	A-S Medication Solutions	b2674075-aaa4-4c77-bcaa-a76336b3c321	2024-10-02	Warnings	Exact identifier application number: M017
Herb Street Anti-Itch Stick	HYDROCORTISONE	Balassa Laboratories Inc.	8717faae-59c3-4c6f-9ef1-285c0d2445ed	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Backache and Sore Muscle Relief	MENTHOL	Balassa Laboratories Inc.	aeac1b64-8689-4b3d-a41c-db41061257b5	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Arthritis Relief	MENTHOL/CAMPHOR	Balassa Laboratories Inc.	a9d8ceb7-def0-415f-8fc1-ff8dd3e41855	2024-10-01	Warnings	Exact identifier application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-Patch	LIDOCAINE	Galaxy Bio, Inc.	2243734a-4ea2-a5e5-e063-6294a90aba15	2024-10-01	Warnings	Exact identifier application number: M017
Medicated Herbal Lip Balm	MENTHOL	Earth Mama Angel Baby LLC	1cc2391e-6a7a-609c-e063-6394a90a6305	2024-10-01	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	NATURAL ESSENTIALS, INC.	1adb9b74-4a01-4461-b845-f3aedcb3f810	2024-10-01	Warnings	Exact identifier application number: M017
Circata	CAPSAICIN	PureTek Corporation	b67161d7-cc5c-e971-e053-2995a90acbe7	2024-10-01	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR,MENTHOL, METHYL SALICYLATE	PureTek Corporation	ffea2e97-777f-434b-e053-6394a90a3a63	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Sore Muscle Relief	METHYL SALICYLATE	Balassa Laboratories Inc.	e43943c2-d4cd-44c5-a0ff-403a8d42860f	2024-10-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Exact identifier application number: M017
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Exact identifier application number: M017
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	8c349cac-20e1-4600-9b0a-fcfe929551c5	2024-09-26	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Exact identifier application number: M017
SYREN Intimate Relief	LIDOCAINE HYDROCHLORIDE	Icon Health Science	57d5a080-3583-4510-e053-2a91aa0ad589	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	ac215c8f-b224-480c-9295-3a34316293ba	4
1314932	Kera-HC 1 % Topical Cream	PSN	ac215c8f-b224-480c-9295-3a34316293ba	4
1314932	hydrocortisone 10 MG/ML Topical Cream [Kera-HC]	SBD	ac215c8f-b224-480c-9295-3a34316293ba	4
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	ac215c8f-b224-480c-9295-3a34316293ba	4
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	ac215c8f-b224-480c-9295-3a34316293ba	4
106258	hydrocortisone 1 % Topical Cream	SY	ac215c8f-b224-480c-9295-3a34316293ba	4
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	ac215c8f-b224-480c-9295-3a34316293ba	4
1314932	Kera-HC 1 % Topical Cream	SY	ac215c8f-b224-480c-9295-3a34316293ba	4
1314932	Kera-HC 10 MG/ML Topical Cream	SY	ac215c8f-b224-480c-9295-3a34316293ba	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44577-623-02	44577062302	56 g in 1 TUBE (44577-623-02)	56 g	2017-02-06	0000-00-00	No	No	Current