Hydrocortisone Butyrate

Product NDC: 68682-384
11-digit product format: 686820384
Labeler code: 68682
Product ID: 68682-384_31d37245-efd3-445f-b6e1-3f4920597dbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCORTISONE BUTYRATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Oceanside Pharmaceuticals
Application: NDA020769
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-07-03
Marketing end: 0000-00-00
Substance: HYDROCORTISONE BUTYRATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68682-384		D	Discontinued by firm	2026-11-06
excluded package	package	68682-384	68682-384-45	D	Discontinued by firm	2026-11-06
excluded package	package	68682-384	68682-384-60	D	Discontinued by firm	2026-11-06

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020769-001	LOCOID LIPOCREAM	HYDROCORTISONE BUTYRATE	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020769-001	AB2

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020769-001	LOCOID LIPOCREAM	0.1%	CREAM / TOPICAL	AB2	RLD, RS	1997-09-08	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020769-001	AB2	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020769-001	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020769-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020769-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020769-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020769-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020769-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020769-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020769-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020769-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020769-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020769-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020769-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020769-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020769-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020769-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020769-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020769-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020769-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020769-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020769-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020769-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020769-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020769-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020769-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020769-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020769-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020769-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020769-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020769-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020769-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020769-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020769-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020769-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020769-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020769-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020769-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020769-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020769-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020769-001	AB2	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68682-384-45	Hydrocortisone Butyrate	45 g in 1 TUBE	CREAM	45	7
68682-384-45	Hydrocortisone Butyrate	1 in 1 CARTON	CREAM	1	7
68682-384-60	Hydrocortisone Butyrate	1 in 1 CARTON	CREAM	1	7
68682-384-60	Hydrocortisone Butyrate	60 g in 1 TUBE	CREAM	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-384-45	GM - Gram	68682-384	e9c0bc84-72fa-48a3-8fe2-5fc4ebe8016d	1	2015-11-12
68682-384-60	GM - Gram	68682-384	d7e5d1c5-99f1-425a-b906-51afca0af662	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE BUTYRATE	ACTIVE INGREDIENT	05RMF7YPWN	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-384	HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS]	6	Legacy NDC, 4 package rows	20241222_ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
05RMF7YPWN	HYDROCORTISONE BUTYRATE	13609-67-1	HYDROCORTISONE BUTYRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1370770	hydrocortisone butyrate 0.1 % Topical Cream	PSN	ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1	7
1370770	hydrocortisone butyrate 1 MG/ML Topical Cream	SCD	ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1	7
1370770	hydrocortisone butyrate 0.1 % Topical Cream	SY	ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-384-45	68682038445	1 TUBE in 1 CARTON (68682-384-45) > 45 g in 1 TUBE	1 tube	2013-07-03	0000-00-00	No	No	Current
68682-384-60	68682038460	1 TUBE in 1 CARTON (68682-384-60) > 60 g in 1 TUBE	1 tube	2013-07-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Butyrate	Oceanside Pharmaceuticals \| Ferndale Laboratories, Inc.	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	7