Home NDC 0113-7426-54 basic care tioconazole 1
Product NDC 0113-7426
Requested package NDC 0113-7426-54
11-digit product format 001137426
Labeler code 0113
Product ID 0113-7426_dfbcbf90-e41e-4abc-8ed7-11de473b196b
Type HUMAN OTC DRUG
Nonproprietary name Tioconazole
Dosage form OINTMENT
Route VAGINAL
Labeler L. Perrigo Company
Application ANDA075915
Marketing category ANDA
Marketing start 2019-05-22
Marketing end 2023-04-01
Substance TIOCONAZOLE
Active strength 7 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075915-001 TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 cb3db0bc1861…
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 · 19 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0113-7426-54 00113742654 1 POUCH in 1 CARTON (0113-7426-54) > 1 APPLICATOR in 1 POUCH > 4.6 g in 1 APPLICATOR 1 pouch 2019-05-22 2023-04-01 No No Current