Exelderm

Product NDC: 69489-721
11-digit product format: 694890721
Labeler code: 69489
Product ID: 69489-721_af026933-9a3d-4027-90f6-57fe4349d11e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulconazole Nitrate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Journey Medical Corporation
Application: NDA018738
Marketing category: NDA
Marketing start: 2019-06-07
Marketing end: 2027-10-31
Substance: SULCONAZOLE NITRATE
Active strength: 10 mg/mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69489-721	69489-721-05	D	Discontinued by firm		2026-08-11

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
N018738-001	EXELDERM	SULCONAZOLE NITRATE	1%	SOLUTION / TOPICAL		RLD, RS	1985-08-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018738-001	EXELDERM	1%	SOLUTION / TOPICAL	RLD, RS	1985-08-30	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Exelderm

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULCONAZOLE NITRATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1T89100D5U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
208118	Internal RxNorm lookup
313125	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
5b73e83e-8d3c-4d96-b4f6-9f854430add8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
312a1339-2d03-1da9-f090-a47730c5330a	Product name	1	20140508
a4a028cc-e548-445b-8dc3-ebf42e7603db	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69489-721-05	Exelderm	5 mL in 1 BOTTLE	SOLUTION	5	3
69489-721-30	Exelderm	1 in 1 CARTON	SOLUTION	1	3
69489-721-30	Exelderm	30 mL in 1 BOTTLE	SOLUTION	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69489-721-30	ML - Milliliter	69489-721	32a82580-19f2-4d48-af79-e4b0ce7355bb	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69489-721	EXELDERM (SULCONAZOLE NITRATE) SOLUTION [JOURNEY MEDICAL CORPORATION]	3	Current NDC, Legacy NDC, 3 package rows	20221110_5b73e83e-8d3c-4d96-b4f6-9f854430add8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exelderm	SULCONAZOLE NITRATE	Journey Medical Corporation	5b73e83e-8d3c-4d96-b4f6-9f854430add8	2026-06-08	Adverse reactions	Exact identifier application applno (NDA): 018738 application number: NDA018738 ndc (product): 69489-721
Sulconazole Nitrate	SULCONAZOLE NITRATE	JG Pharma Inc.	cf6f4340-940c-4a61-b675-456e3297d810	2026-06-08	Adverse reactions	Exact identifier application applno (NDA): 018738 application number: NDA018738

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1T89100D5U	SULCONAZOLE NITRATE	61318-91-0	SULCONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
208118	Exelderm 1 % Topical Solution	PSN	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
313125	sulconazole nitrate 1 % Topical Solution	PSN	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
208118	sulconazole nitrate 10 MG/ML Topical Solution [Exelderm]	SBD	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
313125	sulconazole nitrate 10 MG/ML Topical Solution	SCD	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
208118	Exelderm 1 % Topical Solution	SY	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
208118	Exelderm 10 MG/ML Topical Solution	SY	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3
313125	sulconazole nitrate 1 % Topical Solution	SY	5b73e83e-8d3c-4d96-b4f6-9f854430add8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69489-721-05	69489072105	5 mL in 1 BOTTLE (69489-721-05)	5 ml	2021-03-15	0000-00-00	Yes	No	Current
69489-721-30	69489072130	1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE	1 bottle	2019-06-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exelderm ®	Journey Medical Corporation \| DPT Laboratories, Ltd.	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	4