Hydrocortisone Acetate Cream

Product NDC: 71297-241
11-digit product format: 712970241
Labeler code: 71297
Product ID: 71297-241_3b007d65-4f52-825f-e063-6294a90a71bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone Acetate Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Allegis Holdings LLC
Application: ANDA040396
Marketing category: ANDA
Marketing start: 2025-07-28
Substance: HYDROCORTISONE ACETATE
Active strength: 20 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040396-001	MICORT-HC	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL			2001-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	20 mg/g

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
3b008546-afa5-fe5a-e063-6394a90adb3b	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
71297-241-01	Hydrocortisone Acetate Cream	28.4 g in 1 CARTON	CREAM	28.4		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71297-241-01	GM - Gram	71297-241	07098c8a-7c8e-4820-a39e-63ea75223c91	1	2025-09-12

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Pharmaceuticals, Inc.	57c6aadb-fa88-044f-e063-6394a90a3db8	2026-07-29	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Holdings LLC	3b008546-afa5-fe5a-e063-6394a90adb3b	2025-07-28	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396 ndc (product): 71297-241

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	Sample	Exclude flag	Status
71297-241-01	71297024101	28.4 g in 1 CARTON (71297-241-01)	28.4 g	2025-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone acetate Cream USP 2.5%	Allegis Holdings LLC	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	1