Proctozone

Product NDC: 64980-301
11-digit product format: 649800301
Labeler code: 64980
Product ID: 64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA089682
Marketing category: ANDA
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64980-301		D	Discontinued by firm		2026-08-17
excluded package	package	64980-301	64980-301-30	D	Discontinued by firm		2026-08-17

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-301-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-301-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-301-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-301-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-301-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-301-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-301-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-301-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-301-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-301-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-301-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-301-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089682-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL			1988-03-10

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 · 42 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
2026-08-18 06:07:40	2026-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL		1988-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089682-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089682-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089682-001	AT	1	`cb3db0bc1861…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-301-30	GM - Gram	64980-301	b0cd9ecc-6d12-4b8e-99a8-ff0e9bc0e8ea	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	720357e2-6f01-737d-e053-2a95a90ae54b	2024-06-10	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 089682 application number: ANDA089682

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	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
1440936	Proctozone HC 2.5 % Topical Cream	PSN	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
310891	hydrocortisone 2.5 % Topical Cream	SY	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
1440936	Proctozone HC 2.5 % Topical Cream	SY	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	d7f1f3d3-ce56-43f7-8d3c-3e250fced2d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-301-30	64980030130	1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE	1 tube	2012-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM USP, 2.5% FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE Rx Only	Rising Pharmaceuticals, Inc. \| Actavis Mid Atlantic LLC \| G&W NC Laboratories, LLC	2017-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCORTISONE CREAM USP, 2.5% FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE Rx Only	Physicians Total Care, Inc.	2013-06-12	HUMAN PRESCRIPTION DRUG LABEL	1