Clotrimazole
- Product NDC
- 68788-8330
- Requested package NDC
- 68788-8330-4
- 11-digit product format
- 687888330
- Labeler code
- 68788
- Product ID
- 68788-8330_2acd4dac-129a-47f0-8065-2c831cbf278e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA074165
- Marketing category
- ANDA
- Marketing start
- 2023-01-20
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | caaa826d4ba7… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clotrimazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOTRIMAZOLE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G07GZ97H65 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 309368 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80d67df3-843d-47bb-85a2-d2f26a824336 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8330-4 | Clotrimazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | 4 | |
| 68788-8330-4 | Clotrimazole | 1 in 1 CARTON | CREAM | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8330 | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250309_80d67df3-843d-47bb-85a2-d2f26a824336.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 68788-8330-4 68788-8330 68788833004 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | fd010006-f646-46ed-841a-9f247b19e397 | 2026-03-31 | 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 | 80d67df3-843d-47bb-85a2-d2f26a824336 | 4 |
| 309368 | clotrimazole 10 MG/ML Vaginal Cream | SCD | 80d67df3-843d-47bb-85a2-d2f26a824336 | 4 |
| 309368 | clotrimazole 1 % Vaginal Cream | SY | 80d67df3-843d-47bb-85a2-d2f26a824336 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68788-8330-4 | 68788833004 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8330-4) / 45 g in 1 TUBE, WITH APPLICATOR | 2023-01-20 | No | No | Current |