Hydrocortisone

Product NDC: 45802-004
11-digit product format: 458020004
Labeler code: 45802
Product ID: 45802-004_4b485448-cd59-492b-89cf-8b0582751e44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA085025
Marketing category: ANDA
Marketing start: 2006-03-31
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A085025-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A085025-001	AT

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085025-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A085025-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085025-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085025-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085025-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085025-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085025-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085025-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085025-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085025-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085025-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085025-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085025-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085025-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085025-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085025-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085025-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085025-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085025-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085025-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085025-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085025-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085025-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085025-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085025-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085025-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085025-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085025-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085025-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085025-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085025-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085025-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085025-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085025-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085025-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085025-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085025-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085025-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085025-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085025-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085025-001	AT	1	`f41ea6bd6efb…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103401	Internal RxNorm lookup
310891	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
7ba59aa6-b828-4048-bf86-90c90d9894a0	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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	SPL version
45802-004-02	Hydrocortisone	1 in 1 CARTON	CREAM	1	13
45802-004-02	Hydrocortisone	20 g in 1 TUBE	CREAM	20	13
45802-004-03	Hydrocortisone	1 in 1 CARTON	CREAM	1	13
45802-004-03	Hydrocortisone	28 g in 1 TUBE	CREAM	28	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-004-02	GM - Gram	45802-004	86cfda94-a7d1-4125-93a7-4ef008d22e87	1	2012-07-24
45802-004-03	GM - Gram	45802-004	6d342a99-d8bc-4b23-acf0-dc88ee955e38	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-004	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	12	Current NDC, Legacy NDC, 4 package rows	20240430_7ba59aa6-b828-4048-bf86-90c90d9894a0.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 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	REMEDYREPACK INC.	f0e66726-946b-4f63-b457-2851dc69e6b4	2026-08-03	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2352bb58-a624-4c5e-8966-f68817c30470	2026-04-03	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone Cream	HYDROCORTISONE CREAM	Direct_Rx	19b09776-165a-9579-e063-6294a90a9d39	2026-03-05	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	4b972547-5bd4-155d-e063-6394a90a03ee	2026-03-02	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	2026-02-18	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	7ba59aa6-b828-4048-bf86-90c90d9894a0	2026-01-06	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025 ndc (product): 45802-004
Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	0682580e-aff8-4b67-99ba-a29ab7b433db	2026-01-06	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5d7ae83f-e9ad-4805-812c-919065cb69af	2024-10-02	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b33f51f5-7506-43d3-863b-406dc5c7d167	2023-07-18	Adverse reactions	Exact identifier application applno (ANDA): 085025 application number: ANDA085025

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
310891	hydrocortisone 2.5 % Topical Cream	PSN	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	PSN	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	SY	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 2.5 % Topical Cream	SY	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	PSN	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 2.5 % Topical Cream	SY	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 2.5 % Topical Cream	PSN	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 2.5 % Topical Cream	SY	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 2.5 % Topical Cream	PSN	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 2.5 % Topical Cream	SY	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 2.5 % Topical Cream	PSN	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	PSN	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 2.5 % Topical Ointment	PSN	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 0.025 MG/MG Topical Ointment	SCD	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	SY	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	SY	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 2.5 % Topical Ointment	SY	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 2.5 % Topical Cream	PSN	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 2.5 % Topical Cream	SY	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 2.5 % Topical Cream	PSN	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	PSN	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	SY	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	SY	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 2.5 % Topical Cream	PSN	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 2.5 % Topical Cream	SY	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 2.5 % Topical Cream	PSN	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	PSN	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	SY	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 2.5 % Topical Cream	SY	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	PSN	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	395df967-7532-4de5-a8b3-b34a4b3ace84	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	395df967-7532-4de5-a8b3-b34a4b3ace84	1
310891	hydrocortisone 2.5 % Topical Cream	SY	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 2.5 % Topical Cream	SY	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 2.5 % Topical Cream	SY	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 2.5 % Topical Cream	SY	395df967-7532-4de5-a8b3-b34a4b3ace84	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-004-02	45802000402	1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE	1 tube	2007-01-31	0000-00-00	No	No	Current
45802-004-03	45802000403	1 TUBE in 1 CARTON (45802-004-03) / 28 g in 1 TUBE	1 tube	2006-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	REMEDYREPACK INC.	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	12
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Preferred Pharmaceuticals, Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	13
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	103
Hydrocortisone Cream	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	A-S Medication Solutions	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	18
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Padagis Israel Pharmaceuticals Ltd	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL	13
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	A-S Medication Solutions	2024-10-02	HUMAN PRESCRIPTION DRUG LABEL	14
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	104
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	NuCare Pharmaceuticals,Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCORTISONE CREAM USP, 2.5%	Proficient Rx LP	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2023-07-18	HUMAN PRESCRIPTION DRUG LABEL	104
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Quality Care Products LLC	2022-04-21	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Preferred Pharmaceuticals Inc.	2022-02-23	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Central Texas Community Health Centers \| Travis County Healthcare District	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Aidarex Pharmaceuticals LLC	2017-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE OINTMENT USP, 2.5% HYDROCORTISONE CREAM USP, 2.5%	Rebel Distributors Corp	2012-03-06	HUMAN PRESCRIPTION DRUG LABEL	1