Terbinafine Hydrochloride
- Product NDC
- 70518-0553
- Requested package NDC
- 70518-0553-0
- 11-digit product format
- 705180553
- Labeler code
- 70518
- Product ID
- 70518-0553_bed8b5fb-b4e0-8ec2-e053-2a95a90a1a4a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2017-05-25
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 1 g/100g
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-0553 | 70518-0553-0 | D | Discontinued by firm | 2026-08-11 |
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.
| 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077511-001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 |
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.
| 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 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Scholl's Wellness Company LLC | 31f59302-eaee-211b-e063-6294a90a08b0 | 2026-04-03 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 92b31fc4-0f02-4857-b11f-49b9f942ee84 | 2026-02-20 | Warnings | 077511 ANDA077511 |
| Walgreens Athletes Foot | TERBINAFINE HYDROCHLORIDE | Walgreen Company | d706c56f-0123-4a5a-8c85-240cbe6ef7a5 | 2025-11-26 | Warnings | 077511 ANDA077511 |
| CVS | TERBINAFINE HYDROCHLORIDE | CVS Pharmacy | 17684ba2-3c2c-4259-84fa-3833f19e5a4d | 2025-11-25 | Warnings | 077511 ANDA077511 |
| Good Neighbor Pharmacy | TERBINAFINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0a9e890c-1eed-4fde-a484-852a4dd135c2 | 2025-10-17 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 6016e546-6c02-4af0-888c-c0899865c5f0 | 2025-09-30 | Warnings | 077511 ANDA077511 |
| CVS Pharmacy Athletes Foot | TERBINAFINE HYDROCHLORIDE | CVS Pharmacy | 98a4ed66-2813-49de-8cda-94c41cc3ca9f | 2025-09-25 | Warnings | 077511 ANDA077511 |
| Athletes Foot | TERBINAFINE HYDROCHLORIDE | Publix Super Markets Inc. | 58293d62-089d-49ab-b691-dfd705ac9a9c | 2025-09-25 | Warnings | 077511 ANDA077511 |
| equate Athletes Foot | TERBINAFINE HYDROCHLORIDE | Wal-Mart Stores Inc | e799c808-7c0f-482d-99d2-35fc34dbb2ea | 2025-08-14 | Warnings | 077511 ANDA077511 |
| Good Neighbor Pharmacy | TERBINAFINE HYDROCHLORIDE | AmerisourceBergen | 93ea9e7f-6914-4df2-8ca0-27c453806623 | 2025-07-28 | Warnings | 077511 ANDA077511 |
| Athletes Foot | TERBINAFINE HYDROCHLORIDE | Rite Aid Corporation | a7b0a70b-a117-48cf-a6bc-260be1dac1e7 | 2025-07-28 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 28a3ece3-78fb-4121-86a7-adc4a9d9540f | 2025-07-21 | Warnings | 077511 ANDA077511 |
| Athletes Foot | TERBINAFINE HYDROCHLORIDE | H E B | 28db9a27-4d23-48ef-b1f3-08b993948c11 | 2025-07-15 | Warnings | 077511 ANDA077511 |
| Kroger Antifungal | TERBINAFINE HYDROCHLORIDE | Kroger Company | 32e79416-5de4-4f06-9fff-f8c36a1ad5db | 2025-07-15 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | WALGREEN COMPANY | 2ba1924b-9967-4adb-9061-d023ef44ab3e | 2025-07-10 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Cardinal Health, 110 dba LEADER | a9412747-c7f9-4242-91ed-3695f372f6c9 | 2025-07-09 | Warnings | 077511 ANDA077511 |
| Silka Antifungal | TERBINAFINE HYDROCHLORIDE | Genomma Lab USA, Inc. | a32cf699-e63e-4bd3-a5af-9e1ba447e02e | 2025-07-02 | Warnings | 077511 ANDA077511 |
| Silka Jock Itch | TERBINAFINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 326d8586-042f-44f8-8530-e46b7b777bc3 | 2025-07-02 | Warnings | 077511 ANDA077511 |
| Antifungal | TERBINAFINE HYDROCHLORIDE | Meijer Distribution Inc | 9daf3136-74b6-4410-8256-cbc9dd700f61 | 2025-07-02 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ca9cd2bd-4805-4469-b754-01a7487b71a6 | 2025-07-01 | Warnings | 077511 ANDA077511 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-0553-0 | 70518055300 | 1 TUBE in 1 CARTON (70518-0553-0) > 30 g in 1 TUBE | 1 tube | 2017-05-25 | 0000-00-00 | No | No | Current |