Home NDC 40085-203 Naftifine Hydrochloride
Product NDC 40085-203
11-digit product format 400850203
Labeler code 40085
Product ID 40085-203_b764d26c-4ea7-4aee-a1e8-b0409e9ec2ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NAFTIFINE HYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler Renaissance Pharma, Inc.
Application NDA019599
Marketing category NDA
Marketing start 2016-02-01
Marketing end 2021-08-31
Substance NAFTIFINE HYDROCHLORIDE
Active strength 20 mg/g
Pharmacologic classes Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019599-001 NAFTIN NAFTIFINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 N019599-002 NAFTIN NAFTIFINE HYDROCHLORIDE 2% CREAM / TOPICAL AB RLD, RS 2012-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019599-002 AB
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 3 · 84 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 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019599-001 NAFTIN 1% CREAM / TOPICAL RLD 1988-02-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019599-001 NAFTIN 1% CREAM / TOPICAL RLD 1988-02-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019599-001 NAFTIN 1% CREAM / TOPICAL RLD 1988-02-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019599-001 NAFTIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1988-02-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019599-002 NAFTIN 2% CREAM / TOPICAL AB RLD, RS 2012-01-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N019599-002 M-191 2019-11-10 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N019599-002 M-191 2019-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019599-002 M-191 2019-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019599-002 M-191 2019-11-10 ea99ee380514…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 40085-203-45 40085020345 1 TUBE in 1 CARTON (40085-203-45) > 45 g in 1 TUBE 1 tube 2016-02-01 2021-08-31 No No Current