HYDROCORTISONE

Product NDC: 59898-800
11-digit product format: 598980800
Labeler code: 59898
Product ID: 59898-800_474ac5bb-509d-1f72-e063-6394a90aacdb
Type: HUMAN OTC DRUG
Nonproprietary name: Anti-itch cream
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Water-Jel Technologies
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-04-30
Substance: HYDROCORTISONE ACETATE
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-800-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-800-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-800-36	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-800-32	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-800-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-800-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-800-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-800-36	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-800-32	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-800-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-800-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-800-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-800-36	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-800-32	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-800-02	`bd6a592717d7…`	`303034d00443…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3d34ae31-265a-46bc-a52d-546ea5bb24b6	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59898-800-01	2024-02-13	1% Hydrocortisone Cream
59898-800-02	2024-02-13	1% Hydrocortisone Cream
59898-800-03	2024-02-13	1% Hydrocortisone Cream
59898-800-32	2024-02-13	1% Hydrocortisone Cream
59898-800-36	2024-02-13	1% Hydrocortisone Cream
59898-800-01	2022-01-28	1% Hydrocortisone Cream
59898-800-02	2022-01-28	1% Hydrocortisone Cream
59898-800-03	2022-01-28	1% Hydrocortisone Cream
59898-800-32	2022-01-28	1% Hydrocortisone Cream
59898-800-36	2022-01-28	1% Hydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59898-800-01	HYDROCORTISONE	1728 in 1 CARTON	OINTMENT	1728	7
59898-800-01	HYDROCORTISONE	0.9 g in 1 PACKET	OINTMENT	0.9	7
59898-800-02	HYDROCORTISONE	0.9 g in 1 PACKET	OINTMENT	0.9	7
59898-800-02	HYDROCORTISONE	144 in 1 BOX, UNIT-DOSE	OINTMENT	144	7
59898-800-03	HYDROCORTISONE	25 in 1 BOX, UNIT-DOSE	OINTMENT	25	7
59898-800-03	HYDROCORTISONE	0.9 g in 1 PACKET	OINTMENT	0.9	7
59898-800-32	HYDROCORTISONE	28 g in 1 TUBE	OINTMENT	28	7
59898-800-36	HYDROCORTISONE	0.9 g in 1 PACKET	OINTMENT	0.9	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59898-800	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]	6	Current NDC, Legacy NDC, 8 package rows	20240214_3d34ae31-265a-46bc-a52d-546ea5bb24b6.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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL BREEZE Pain Relief	MENTHOL	COOL BREEZE US LLC	14dcf4ee-6778-49d4-8601-9205737432ea	2023-11-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	1ebb45e5-4541-4c95-abe1-661ef763a610	2023-11-01	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Cream	LIDOCAINE 4%	Walgreens	ce1b55ed-f5c5-ea8b-e053-2a95a90acd40	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens pain relieving	LIDOCAINE 4%	Walgreens	ce2b9e57-749d-715c-e053-2995a90aaf8d	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens Cool n heat	LIDOCAINE 4% MENTHOL 1%	Walgreens	ce168ab7-ec4a-daea-e053-2995a90af829	2023-10-31	Warnings	Exact identifier application number: M017
Methyl Salicylate 40 Percent	METHYL SALICYLATE	Alexso, Inc	53407aab-094c-4393-a2b9-54fd85321e3e	2023-10-31	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bentlin Products LLC	4346351c-8e11-46ae-b428-98d17f55beb9	2023-10-30	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59898-800-01	59898080001	1728 PACKET in 1 CARTON (59898-800-01) / .9 g in 1 PACKET	1728 packet	2010-04-30	0000-00-00	No	No	Current
59898-800-02	59898080002	144 PACKET in 1 BOX, UNIT-DOSE (59898-800-02) / .9 g in 1 PACKET	144 packet	2010-04-30	0000-00-00	No	No	Current
59898-800-03	59898080003	25 PACKET in 1 BOX, UNIT-DOSE (59898-800-03) / .9 g in 1 PACKET	25 packet	2010-04-30	0000-00-00	No	No	Current
59898-800-32	59898080032	28 g in 1 TUBE (59898-800-32)	28 g	2010-04-30	0000-00-00	No	No	Current
59898-800-36	59898080036	.9 g in 1 PACKET (59898-800-36)		2010-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
1% Hydrocortisone Cream	Water-Jel Technologies	2025-12-31	HUMAN OTC DRUG LABEL	7
HYDROCORTISONE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2025-08-05	HUMAN OTC DRUG LABEL	1
First Aid Only Hydrocortisone 1% Anti-Itch Cream	Acme United Corporation	2024-11-19	HUMAN OTC DRUG LABEL	2