Oxistat

Product NDC: 10337-359
11-digit product format: 103370359
Labeler code: 10337
Product ID: 10337-359_c31b3c09-29fc-45ca-a742-3b5a9f553517
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxiconazole nitrate
Dosage form: LOTION
Route: TOPICAL
Labeler: PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application: NDA020209
Marketing category: NDA
Marketing start: 1992-09-30
Marketing end: 0000-00-00
Substance: OXICONAZOLE NITRATE
Active strength: 10 mg/mL
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10337-359		D	Discontinued by firm	2026-09-14
excluded package	package	10337-359	10337-359-07	D	Discontinued by firm	2026-09-14
excluded package	package	10337-359	10337-359-30	D	Discontinued by firm	2026-09-14
excluded package	package	10337-359	10337-359-60	D	Discontinued by firm	2026-09-14
excluded package	package	10337-359	10337-359-66	D	Discontinued by firm	2026-09-14

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 · 55 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	10337-359-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10337-359-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10337-359-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10337-359-60	`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	10337-359-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10337-359-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10337-359-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10337-359-60	`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	10337-359-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10337-359-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10337-359-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10337-359-60	`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	10337-359-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10337-359-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10337-359-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10337-359-60	`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	10337-359-66	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10337-359-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10337-359-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10337-359-60	`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	10337-359-66	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10337-359-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10337-359-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10337-359-60	`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	10337-359-66	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10337-359-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10337-359-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10337-359-60	`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	10337-359-66	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10337-359-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10337-359-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10337-359-60	`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	10337-359-66	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10337-359-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10337-359-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10337-359-60	`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	10337-359-66	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10337-359-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10337-359-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10337-359-60	`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	10337-359-66	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10337-359-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10337-359-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10337-359-60	`367a005e9d99…`	`383a685ebd0f…`

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
N020209-001	OXISTAT	OXICONAZOLE NITRATE	EQ 1% BASE	LOTION / TOPICAL		RLD	1992-09-30

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD	1992-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD	1992-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020209-001	OXISTAT	EQ 1% BASE	LOTION / TOPICAL	RLD, RS	1992-09-30	`f41ea6bd6efb…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10337-359-07	2020-09-11	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-30	2020-09-11	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-60	2020-09-11	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-66	2020-09-11	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-07	2020-07-22	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-30	2020-07-22	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-60	2020-07-22	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*
10337-359-66	2020-07-22	OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10337-359-30	ML - Milliliter	10337-359	bdfc33a1-fd8f-4edc-ab4b-599332e7e077	1	2013-02-13
10337-359-60	ML - Milliliter	10337-359	b4d2e581-e57c-4449-860d-1e06ad4a749f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
oxiconazole nitrate	ACTIVE INGREDIENT	RQ8UL4C17S	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
oxiconazole	ACTIVE MOIETY	C668Q9I33J	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13
water	INACTIVE INGREDIENT	059QF0KO0R	OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxistat	OXICONAZOLE NITRATE	ANI Pharmaceuticals, Inc.	64ef2286-0f56-4a8a-b07b-4a597f078ae0	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020209 application number: NDA020209

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RQ8UL4C17S	OXICONAZOLE NITRATE	64211-46-7	OXICONAZOLE NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10337-359-07	10337035907	7 mL in 1 BOTTLE (10337-359-07)	7 ml	1992-09-30	0000-00-00	No	No	Current
10337-359-30	10337035930	1 BOTTLE in 1 CARTON (10337-359-30) > 30 mL in 1 BOTTLE	1 bottle	1992-09-30	0000-00-00	No	No	Current
10337-359-60	10337035960	1 BOTTLE in 1 CARTON (10337-359-60) > 60 mL in 1 BOTTLE	1 bottle	1992-09-30	0000-00-00	No	No	Current
10337-359-66	10337035966	6 BOTTLE in 1 CARTON (10337-359-66) > 7 mL in 1 BOTTLE	6 bottle	1992-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXISTAT ® (oxiconazole nitrate) Cream, 1%* OXISTAT ® (oxiconazole nitrate) Lotion, 1%*	PharmaDerm a division of Fougera Pharmaceuticals Inc.	2020-09-10	HUMAN PRESCRIPTION DRUG LABEL	18