PREPARATION H HYDROCORTISONE

Product NDC: 0573-2830
11-digit product format: 005732830
Labeler code: 0573
Product ID: 0573-2830_128ad543-e543-6322-e063-6294a90a2743
Type: HUMAN OTC DRUG
Nonproprietary name: hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Haleon US Holdings LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-01
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

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 · 6 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	0573-2830-10	`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	0573-2830-10	`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	0573-2830-10	`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: PREPARATION H HYDROCORTISONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310868	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
b8d531eb-4012-0450-0e4b-70a808464041	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-2830-10	2024-02-29	C162847	48780-1	d6a99b39-9920-a426-e053-dadaa90af4c2	Drug Facts
0573-2830-10	2022-01-28	C162847	48780-1	d6a99b39-9920-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0573-2830-10	PREPARATION H HYDROCORTISONE	1 in 1 CARTON	CREAM	1		8
0573-2830-10	PREPARATION H HYDROCORTISONE	26 g in 1 TUBE	CREAM	26		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2830-10	GM - Gram	0573-2830	0965d4da-363e-4cde-8b54-fac02b9c7bb4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	PREPARATION H HYDROCORTISONE (HYDROCORTISONE) CREAM [PFIZER CONSUMER HEALTHCARE]	3
hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	PREPARATION H HYDROCORTISONE (HYDROCORTISONE) CREAM [PFIZER CONSUMER HEALTHCARE]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2830	PREPARATION H HYDROCORTISONE (HYDROCORTISONE) CREAM [HALEON US HOLDINGS LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240302_b8d531eb-4012-0450-0e4b-70a808464041.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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	1cada0ae-3f0f-441c-a633-faa0a3009d2b	2026-02-05	Warnings	Exact identifier application number: M015
Numbing Cream	LIDOCAINE	Sainite Trading Shenzhen Co., Ltd.	49fcbe81-34b6-5906-e063-6294a90aa65b	2026-02-04	Warnings	Exact identifier application number: M015
Perineal Cooling Pad Liners	FRIDA MOM PERINEAL COOLING PAD LINERS	Fridababy, LLC	e9d33d92-34ee-b639-e053-2a95a90a9f36	2026-02-04	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Sportpharm LLC	88e3624d-b8bb-4e65-9250-4c51d2bbed16	2026-02-03	Warnings	Exact identifier application number: M015
careone hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	American Sales Company	46794d2e-8fe6-490d-9cfa-ba9b6c209ad6	2026-01-29	Warnings	Exact identifier application number: M015
LUBRICAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	9d98afbf-11ce-745b-e053-2a95a90abc14	2026-01-28	Warnings	Exact identifier application number: M015
foster and thrive hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	9da843f2-e88c-432e-b091-a6acf81d856b	2026-01-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	HyVee Inc	bf1beca0-cc9b-4100-9db7-77f2d1e5497c	2026-01-21	Warnings	Exact identifier application number: M015
GRANULOTION Hemorrhoidal	MENTHOL, ZINC OXIDE	GL Health, Inc.	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	2026-01-19	Warnings	Exact identifier application number: M015
Hydroseptine	ZINC OXIDE, MENTHOL	AKRON PHARMA INC	5359d92e-641e-4076-9d91-18daee58a30e	2026-01-19	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	1ac2b2ae-c090-483b-ad2c-1374552add4a	2026-01-15	Warnings	Exact identifier application number: M015
Walgreens	HEMORRHOIDAL PAIN RELIEF	Walgreens	b0b1ce47-9fa4-4505-8f38-39a0d500e9f6	2026-01-15	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	4276ddad-2363-462a-bb97-574f946ec3f0	2026-01-15	Warnings	Exact identifier application number: M015
Walgreens	HEMORRHOIDAL COOLING GEL	Walgreens	1277d2e8-2a5e-23f5-e063-6294a90a69b0	2026-01-15	Warnings	Exact identifier application number: M015
Hemorrhoid and Fissure	GLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%	FlexiGo Inc	48697377-61c0-1b0a-e063-6294a90a3293	2026-01-15	Warnings	Exact identifier application number: M015
MEDPURA Vitamin A and D Vitamin A and D	MEDPURA VITAMIN A AND D	Akron Pharma Inc.	38cc2317-691b-4657-af05-c67623eba760	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	2dd710ac-ab04-4a24-826f-b5a44d058168	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	ca98dea5-767d-49a8-887b-d96cad487fc4	2026-01-14	Warnings	Exact identifier application number: M015
Walgreens Moisture Barrier	MENTHOL, AND ZINC OXIDE	Walgreen Company	a6db6f13-4e02-47dc-aef6-a804506c3d8b	2026-01-14	Warnings	Exact identifier application number: M015
GNP Hemorrhoidal Maximum Strength	HEMORRHOIDAL	Amerisourcebergen Drug Corporation	24103355-cd72-55b0-e063-6394a90a90ec	2026-01-14	Warnings	Exact identifier application number: M015

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
310868	hydrocortisone 1 % Rectal Cream	PSN	b8d531eb-4012-0450-0e4b-70a808464041	8
310868	hydrocortisone 10 MG/ML Rectal Cream	SCD	b8d531eb-4012-0450-0e4b-70a808464041	8
310868	hydrocortisone 1 % Rectal Cream	SY	b8d531eb-4012-0450-0e4b-70a808464041	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2830-10	00573283010	1 TUBE in 1 CARTON (0573-2830-10) / 26 g in 1 TUBE	1 tube	2004-01-01	0000-00-00	No	No	Current