Naftin

Product NDC: 54766-772
11-digit product format: 547660772
Labeler code: 54766
Product ID: 54766-772_43150f38-df38-5e12-e063-6294a90a1128
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naftifine Hydrochloride
Dosage form: GEL
Route: TOPICAL
Labeler: Sebela Pharmaceuticals Inc.
Application: NDA204286
Marketing category: NDA
Marketing start: 2018-03-01
Marketing end: 2026-10-31
Substance: NAFTIFINE HYDROCHLORIDE
Active strength: 2 g/100g
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Current FDA listing: Yes

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
N204286-001	NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204286-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204286-001	10166205	2033-01-31		Drug product	2019-04-19
N204286-001	10166206	2033-01-31		Drug product	2019-04-19
N204286-001	10695303	2033-01-31		Drug product	2020-07-27
N204286-001	10729667	2033-01-31		Drug product	2020-08-31
N204286-001	8778365	2033-01-31		Drug product	2014-07-22
N204286-001	9161914	2033-01-31	U-540		2015-11-03

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204286-001	NAFTIN	2%	GEL / TOPICAL		RLD, RS	2013-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204286-001	NAFTIN	2%	GEL / TOPICAL	AB	RLD, RS	2013-06-27	`e64feba35796…`

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
2026-08-18 06:07:40	2026-07	N204286-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204286-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204286-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204286-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204286-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204286-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204286-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204286-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204286-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204286-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204286-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204286-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204286-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204286-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204286-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204286-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204286-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204286-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204286-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204286-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204286-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204286-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204286-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204286-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204286-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204286-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204286-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204286-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204286-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204286-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204286-001	AB	1	`3f0d92c62455…`
2023-01-26 05:58 UTC	2023-01	N204286-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204286-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204286-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204286-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204286-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 244 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	8778365	2033-01-31		Drug product	2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204286-001	9161914	2033-01-31	U-540		2015-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	10166205	2033-01-31		Drug product	2019-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	10166206	2033-01-31		Drug product	2019-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	10695303	2033-01-31		Drug product	2020-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204286-001	10729667	2033-01-31		Drug product	2020-08-31	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naftin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAFTIFINE HYDROCHLORIDE	2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
25UR9N9041	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1433734	Internal RxNorm lookup
1433736	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
6645994a-ecb3-277b-e053-2a91aa0a81e5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f630d5a-8a28-4ac5-8ede-8b54b7617055	Product name	3	20210512
6aca302d-6492-4ac9-8829-e023cb64c91c	Product name	1	20190627
ba2e3195-29b1-b94a-4345-149632e97b51	Product name	3	20161117
7ac69d99-c06d-0e83-7872-6229bc9878f9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54766-772-45	Naftin	45 g in 1 TUBE	GEL	45	7
54766-772-45	Naftin	1 in 1 CARTON	GEL	1	7
54766-772-60	Naftin	60 g in 1 TUBE	GEL	60	7
54766-772-60	Naftin	1 in 1 CARTON	GEL	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54766-772-45	GM - Gram	54766-772	52a870e5-8fe1-4f19-a67b-61b3612cbb7d	1	2018-03-08
54766-772-60	GM - Gram	54766-772	690d4f34-9597-49e4-a125-5c8cf13aa2d9	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54766-772	NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [SEBELA PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 4 package rows	20231213_6645994a-ecb3-277b-e053-2a91aa0a81e5.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
Naftin	NAFTIFINE HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	6645994a-ecb3-277b-e053-2a91aa0a81e5	2025-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204286 application number: NDA204286 ndc (product): 54766-772
Naftin	NAFTIFINE HYDROCHLORIDE	Legacy Pharma USA Inc.	6c6ee055-4031-45a7-8561-ccd989343580	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204286 application number: NDA204286

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
25UR9N9041	NAFTIFINE HYDROCHLORIDE	65473-14-5	NAFTIFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1433734	naftifine HCl 2 % Topical Gel	PSN	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433736	NAFTIN 2 % Topical Gel	PSN	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433736	naftifine hydrochloride 0.02 MG/MG Topical Gel [Naftin]	SBD	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433734	naftifine hydrochloride 0.02 MG/MG Topical Gel	SCD	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433734	naftifine hydrochloride 2 % Topical Gel	SY	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433736	Naftin 0.02 MG/MG Topical Gel	SY	6645994a-ecb3-277b-e053-2a91aa0a81e5	7
1433736	Naftin 2 % Topical Gel	SY	6645994a-ecb3-277b-e053-2a91aa0a81e5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54766-772-45	54766077245	1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE	1 tube	2018-03-01	2026-10-31	No	No	Current
54766-772-60	54766077260	1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE	1 tube	2018-03-01	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naftin	Sebela Pharmaceuticals Inc. \| Ferndale Laboratories, Inc.	2025-11-08	HUMAN PRESCRIPTION DRUG LABEL	7