HYDROCORTISONE

Product NDC: 61919-364
11-digit product format: 619190364
Labeler code: 61919
Product ID: 61919-364_4c493737-c816-c313-e063-6394a90aa366
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCORTISONE
Dosage form: CREAM
Route: TOPICAL
Labeler: DIRECT RX
Application: ANDA088799
Marketing category: ANDA
Marketing start: 2014-01-01
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

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-364-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-364-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-364-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-364-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-364-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-364-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-364-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-364-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-364-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-364-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A088799-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		1984-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088799-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088799-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1984-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088799-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088799-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088799-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088799-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088799-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088799-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088799-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088799-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088799-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088799-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088799-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088799-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088799-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088799-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088799-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088799-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088799-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088799-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088799-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088799-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088799-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088799-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088799-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088799-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088799-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088799-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088799-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088799-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088799-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088799-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088799-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088799-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088799-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088799-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088799-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088799-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088799-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088799-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088799-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088799-001	AT	1	`cb3db0bc1861…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3d017594-3a00-40ba-b392-1699992fa1b1	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
61919-364-30	2025-01-30	C162847	48780-1	2cef2736-ad3d-d83d-e063-dadaa90ab31f	HYDROCORTISONE CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-364-28	HYDROCORTISONE	28 g in 1 TUBE	CREAM	28		6
61919-364-30	HYDROCORTISONE	30 g in 1 TUBE	CREAM	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-364-30	GM - Gram	61919-364	02e4845d-101a-4c45-9d73-8ea758a712bb	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [DIRECT RX]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [DIRECT RX]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [DIRECT RX]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [DIRECT RX]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [DIRECT RX]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [DIRECT RX]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [DIRECT RX]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM [DIRECT RX]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE CREAM [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [DIRECT RX]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [DIRECT RX]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM [DIRECT RX]	1
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-364	HYDROCORTISONE CREAM [DIRECT RX]	5	Current NDC, Legacy NDC, 2 package rows	20230420_3d017594-3a00-40ba-b392-1699992fa1b1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	3d017594-3a00-40ba-b392-1699992fa1b1	2026-03-05	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799 ndc (product): 61919-364
Proctosol-HC	HYDROCORTISONE	Bryant Ranch Prepack	68e177fd-87aa-45f3-a380-0d092abdb77d	2025-11-05	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	e4f22e9c-cf38-473a-8f7d-8da7fd696f76	2025-10-02	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
Proctosol-HC	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	565284e7-4994-486b-8267-18bd166655ac	2025-07-02	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Exact identifier application applno (ANDA): 088799 application number: ANDA088799

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	3d017594-3a00-40ba-b392-1699992fa1b1	6
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	3d017594-3a00-40ba-b392-1699992fa1b1	6
310891	hydrocortisone 2.5 % Topical Cream	SY	3d017594-3a00-40ba-b392-1699992fa1b1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-364-28	61919036428	28 g in 1 TUBE (61919-364-28)	28 g	2014-01-01		No	No	Current
61919-364-30	61919036430	30 g in 1 TUBE (61919-364-30)	30 g	2015-01-01	0000-00-00	No	No	Current