Naftin

Product NDC
54766-772
Requested package NDC
54766-772-45
11-digit product format
547660772
Labeler code
54766
Product ID
54766-772_a3e490ad-14ef-7f9c-e053-2995a90a34bb
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
0000-00-00
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
2 g/100g
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54766-77254766-772-45DDiscontinued by firm2026-11-13

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204286-001NAFTINNAFTIFINE HYDROCHLORIDE2%GEL / TOPICALABRLD, RS2013-06-27

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204286-001101662052033-01-31Drug product2019-04-19
N204286-001101662062033-01-31Drug product2019-04-19
N204286-001106953032033-01-31Drug product2020-07-27
N204286-001107296672033-01-31Drug product2020-08-31
N204286-00187783652033-01-31Drug product2014-07-22
N204286-00191619142033-01-31U-5402015-11-03

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 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27d4dbc9d85df4…
2026-10-15 13:18:302026-09N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27c2088c7a36db…
2026-09-14 22:38:342026-08N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2784e616aacf4f…
2026-08-18 06:07:402026-07N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-273f01610625f2…
2019-09-15 20:21 UTC2019-09N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N204286-001NAFTIN2%GEL / TOPICALRLD, RS2013-06-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N204286-001NAFTIN2%GEL / TOPICALABRLD, RS2013-06-273bdfa0b2c4d7…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-11-14 07:37:172026-10N204286-001AB1d4dbc9d85df4…
2026-10-15 13:18:302026-09N204286-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N204286-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N204286-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204286-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204286-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204286-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204286-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204286-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204286-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204286-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204286-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204286-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204286-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204286-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204286-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204286-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204286-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204286-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204286-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204286-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204286-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204286-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204286-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N204286-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204286-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204286-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204286-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N204286-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N204286-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204286-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204286-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204286-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204286-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204286-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204286-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204286-001AB13f0d92c62455…
2023-01-26 05:58 UTC2023-01N204286-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204286-001AB13a93d1ddd44b…

Observed Orange Book patent history#

Patent history page 1 of 7 · 262 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-11-14 07:37:172026-10N204286-001101662052033-01-31Drug product2019-04-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N204286-001101662062033-01-31Drug product2019-04-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N204286-001106953032033-01-31Drug product2020-07-27d4dbc9d85df4…
2026-11-14 07:37:172026-10N204286-001107296672033-01-31Drug product2020-08-31d4dbc9d85df4…
2026-11-14 07:37:172026-10N204286-00187783652033-01-31Drug product2014-07-22d4dbc9d85df4…
2026-11-14 07:37:172026-10N204286-00191619142033-01-31U-5402015-11-03d4dbc9d85df4…
2026-10-15 13:18:302026-09N204286-001101662052033-01-31Drug product2019-04-19c2088c7a36db…
2026-10-15 13:18:302026-09N204286-001101662062033-01-31Drug product2019-04-19c2088c7a36db…
2026-10-15 13:18:302026-09N204286-001106953032033-01-31Drug product2020-07-27c2088c7a36db…
2026-10-15 13:18:302026-09N204286-001107296672033-01-31Drug product2020-08-31c2088c7a36db…
2026-10-15 13:18:302026-09N204286-00187783652033-01-31Drug product2014-07-22c2088c7a36db…
2026-10-15 13:18:302026-09N204286-00191619142033-01-31U-5402015-11-03c2088c7a36db…
2026-09-14 22:38:342026-08N204286-001101662052033-01-31Drug product2019-04-1984e616aacf4f…
2026-09-14 22:38:342026-08N204286-001101662062033-01-31Drug product2019-04-1984e616aacf4f…
2026-09-14 22:38:342026-08N204286-001106953032033-01-31Drug product2020-07-2784e616aacf4f…
2026-09-14 22:38:342026-08N204286-001107296672033-01-31Drug product2020-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N204286-00187783652033-01-31Drug product2014-07-2284e616aacf4f…
2026-09-14 22:38:342026-08N204286-00191619142033-01-31U-5402015-11-0384e616aacf4f…
2026-08-18 06:07:402026-07N204286-001101662052033-01-31Drug product2019-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204286-001101662062033-01-31Drug product2019-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204286-001106953032033-01-31Drug product2020-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07N204286-001107296672033-01-31Drug product2020-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N204286-00187783652033-01-31Drug product2014-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N204286-00191619142033-01-31U-5402015-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204286-001101662052033-01-31Drug product2019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204286-001101662062033-01-31Drug product2019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204286-001106953032033-01-31Drug product2020-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204286-001107296672033-01-31Drug product2020-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204286-00187783652033-01-31Drug product2014-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204286-00191619142033-01-31U-5402015-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001101662052033-01-31Drug product2019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001101662062033-01-31Drug product2019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001106953032033-01-31Drug product2020-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-001107296672033-01-31Drug product2020-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-00187783652033-01-31Drug product2014-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204286-00191619142033-01-31U-5402015-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N204286-001101662052033-01-31Drug product2019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204286-001101662062033-01-31Drug product2019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204286-001106953032033-01-31Drug product2020-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204286-001107296672033-01-31Drug product2020-08-316a471c1ec25d…

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 conceptRelationVersionEffective
8f630d5a-8a28-4ac5-8ede-8b54b7617055Product name320210512
6aca302d-6492-4ac9-8829-e023cb64c91cProduct name120190627
ba2e3195-29b1-b94a-4345-149632e97b51Product name320161117
7ac69d99-c06d-0e83-7872-6229bc9878f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54766-772-45Naftin45 g in 1 TUBEGEL457
54766-772-45Naftin1 in 1 CARTONGEL17
54766-772-60Naftin60 g in 1 TUBEGEL607
54766-772-60Naftin1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-772-45GM - Gram54766-77252a870e5-8fe1-4f19-a67b-61b3612cbb7d12018-03-08
54766-772-60GM - Gram54766-772690d4f34-9597-49e4-a125-5c8cf13aa2d912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-772NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [SEBELA PHARMACEUTICALS INC.]5Legacy NDC, 4 package rows20231213_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaftinNAFTIFINE HYDROCHLORIDELegacy Pharma USA Inc.6c6ee055-4031-45a7-8561-ccd9893435802025-07-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 204286
application number: NDA204286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433734naftifine HCl 2 % Topical GelPSN6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736NAFTIN 2 % Topical GelPSN6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736naftifine hydrochloride 0.02 MG/MG Topical Gel [Naftin]SBD6645994a-ecb3-277b-e053-2a91aa0a81e57
1433734naftifine hydrochloride 0.02 MG/MG Topical GelSCD6645994a-ecb3-277b-e053-2a91aa0a81e57
1433734naftifine hydrochloride 2 % Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736Naftin 0.02 MG/MG Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736Naftin 2 % Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-772-45547660772451 TUBE in 1 CARTON (54766-772-45) > 45 g in 1 TUBE1 tube2018-03-010000-00-00NoNoCurrent