NAFTIFINE HYDROCHLORIDE

Product NDC
0115-1512
11-digit product format
001151512
Labeler code
0115
Product ID
0115-1512_6cf7b001-6ec3-4d9d-a6b0-7231ecbf3c2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFTIFINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA206960
Marketing category
ANDA
Marketing start
2017-05-10
Marketing end
0000-00-00
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
20 mg/g
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0115-1512DDiscontinued by firm2026-08-03
excluded packagepackage0115-15120115-1512-45DDiscontinued by firm2026-08-03
excluded packagepackage0115-15120115-1512-46DDiscontinued by firm2026-08-03
excluded packagepackage0115-15120115-1512-58DDiscontinued by firm2026-08-03

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1512-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1512-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1512-58d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1512-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1512-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1512-58f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1512-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1512-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1512-582ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1512-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1512-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1512-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1512-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1512-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1512-58cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1512-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1512-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1512-58cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1512-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1512-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1512-58302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1512-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1512-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1512-58ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1512-460efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1512-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1512-580efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1512-46ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1512-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1512-58ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1512-46367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1512-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1512-58367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1512-46557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1512-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1512-58557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206960-001NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE2%CREAM / TOPICAL2017-04-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-103f01610625f2…
2019-09-15 20:21 UTC2019-09A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206960-001NAFTIFINE HYDROCHLORIDE2%CREAM / TOPICALAB2017-04-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206960-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206960-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206960-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206960-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206960-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206960-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206960-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206960-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206960-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206960-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206960-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206960-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206960-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206960-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206960-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206960-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206960-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206960-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206960-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206960-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206960-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206960-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206960-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206960-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206960-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206960-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206960-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206960-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206960-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206960-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206960-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206960-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206960-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206960-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206960-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206960-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206960-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206960-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206960-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206960-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1512-46GM - Gram0115-15128b9e102f-fcbc-4e48-a224-3e1119ab8d2012017-06-15
0115-1512-58GM - Gram0115-1512f66fe560-b7cf-4ad2-8631-02bae55aa96612017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1512-45001151512451 TUBE in 1 CARTON (0115-1512-45) > 30 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
0115-1512-46001151512461 TUBE in 1 CARTON (0115-1512-46) > 45 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
0115-1512-58001151512581 TUBE in 1 CARTON (0115-1512-58) > 60 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent