Clotrimazole
- Product NDC
- 68071-2614
- 11-digit product format
- 680712614
- Labeler code
- 68071
- Product ID
- 68071-2614_d505c338-ddbf-26eb-e053-2a95a90a0261
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA074165
- Marketing category
- ANDA
- Marketing start
- 2021-06-29
- Marketing end
- 0000-00-00
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 68071-2614 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 68071-2614 | 68071-2614-4 | I | Inactivated by FDA | 2026-08-07 |
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2614-4 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2614-4 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2614-4 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2614-4 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074165-001 | CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 |
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 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2614-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5b8e-d83d-e063-dadaa90ab31f | Clotrimazole |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2614-4 | Clotrimazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | 1 | |
| 68071-2614-4 | Clotrimazole | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2614 | CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 2 package rows | 20220217_d505c338-ddbe-26eb-e053-2a95a90a0261.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clotrimazole | CLOTRIMAZOLE | Walgreens | 7ca79361-6608-4eda-ba5b-16c28eb6c019 | 2026-06-09 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | 80d67df3-843d-47bb-85a2-d2f26a824336 | 2026-03-31 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | fd010006-f646-46ed-841a-9f247b19e397 | 2026-03-31 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | Rite Aid Corporation | 384c8113-87aa-4fbd-942a-5f02c4e88536 | 2025-10-14 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | Strategic Sourcing Services LLC | de3b6b64-dfa5-4abd-ba43-4ab59b4c2284 | 2025-09-09 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | Cardinal Health (Leader) 70000 | 4aaae616-179b-40f1-8a39-6a1ddd414070 | 2025-04-29 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | 6b908538-d9ff-41d0-909c-01e1d1b21a39 | 2024-10-23 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | QUALITY CHOICE (Chain Drug Marketing Association) | 3c676ff0-44a8-40cd-8f85-d39dda3d9637 | 2024-05-23 | Warnings | 074165 ANDA074165 |
| Clotrimazole | CLOTRIMAZOLE | H2-Pharma, LLC | 388f7e35-efbe-496b-a8d6-518caa22328d | 2023-01-11 | Warnings | 074165 ANDA074165 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309368 | clotrimazole 1 % Vaginal Cream | PSN | d505c338-ddbe-26eb-e053-2a95a90a0261 | 1 |
| 309368 | clotrimazole 10 MG/ML Vaginal Cream | SCD | d505c338-ddbe-26eb-e053-2a95a90a0261 | 1 |
| 309368 | clotrimazole 1 % Vaginal Cream | SY | d505c338-ddbe-26eb-e053-2a95a90a0261 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2614-4 | 68071261404 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68071-2614-4) > 45 g in 1 TUBE, WITH APPLICATOR | 2022-01-07 | 0000-00-00 | No | No | Current |