Tolnaftate Cream 1%
- Product NDC
- 68016-152
- 11-digit product format
- 680160152
- Labeler code
- 68016
- Product ID
- 68016-152_29b74830-546d-c90b-e063-6294a90a4e72
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Pharmacy Value Alliance, LLC.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-08-23
- Substance
- TOLNAFTATE
- Active strength
- 10 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Tolnaftate Cream 1%
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06KB629TKV | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 103951 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3abfd734-229b-1a0e-e054-00144ff88e88 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-05-09 | Tolnaftate Cream 1% |
| 2023-01-30 | Tolnaftate Cream 1% |
| 2021-08-10 | Tolnaftate Cream 1% |
| 2021-01-29 | Tolnaftate Cream 1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-152-01 | Tolnaftate Cream 1% | 1 in 1 BOX | CREAM | 1 | 5 | |
| 68016-152-01 | Tolnaftate Cream 1% | 28 g in 1 TUBE | CREAM | 28 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-152-01 | EA - Each | 68016-152 | 01999020-6fdb-4813-a13b-923a8c8acb56 | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Bee Venom Toenail Fungus Treatment | BEE VENOM TOENAIL FUNGUS TREATMENT | Shenzhen Earth Surface Trading Co., Ltd. | 457c705a-9c49-c8c5-e063-6394a90a6aa3 | 2025-12-08 | Warnings | M005 |
| Tolnaftate Antifungal Powder | TOLNAFTATE | SCHOLL'S WELLNESS COMPANY LLC | 2a0e006b-60b1-41b9-a5d2-ff0e34b48ff5 | 2025-12-06 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | 1e7e74f6-9bca-48ab-804a-a7a81df3b608 | 2025-12-05 | Warnings | M005 |
| Oiangna Tea Tree Oil Antifungal | CLOTRIMAZOLE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 453452a7-c613-6111-e063-6294a90aca81 | 2025-12-05 | Warnings | M005 |
| Tinactin Antifungal | TOLNAFTATE | Bayer HealthCare LLC. | 5f95be36-6efa-4dfb-9a40-88f4ce1de2b3 | 2025-12-05 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | c3b715a9-233a-401a-ba60-f78c1ddf1ded | 2025-12-05 | Warnings | M005 |
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC. | b584e17f-ed43-43bd-b643-dfa48edd78c6 | 2025-12-05 | Warnings | M005 |
| Fungicure Night Cream | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 43029403-2afd-cfa1-e063-6394a90a99a3 | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevention Deo | TOLNAFTATE | Bayer HealthCare LLC. | 9e8bfb78-ad81-93d0-e053-2995a90aa41d | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Jock Itch | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 0c53cf0f-767e-a422-e063-6394a90ab764 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0a80a5b0-3216-46f6-8801-7066ef59aee4 | 2025-12-04 | Warnings | M005 |
| Lotrimin Antifungal | CLOTRIMAZOLE | Bayer HealthCare LLC. | f9536683-3f32-4c71-9b6a-70f8611e3dcf | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Deodorant | MICONAZOLE NITRATE | Bayer HealthCare LLC. | 0bee54eb-df2f-15fe-e063-6294a90a2fd2 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0beda157-efd2-5245-e063-6394a90a6911 | 2025-12-04 | Warnings | M005 |
| Lotrimin AF | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 163996c6-af54-21ac-e063-6394a90ac05c | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevent Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1bb961cd-b6e6-3aff-e063-6394a90a432e | 2025-12-04 | Warnings | M005 |
| Tinactin Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1751d576-e94a-d7d1-e063-6294a90a03ff | 2025-12-04 | Warnings | M005 |
| Tinactin Jock Itch | TOLNAFTATE | Bayer HealthCare LLC | 163ab4df-6e4a-6239-e063-6294a90a1cd0 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC | bb878f31-2189-4427-aacf-5bce96d75978 | 2025-12-04 | Warnings | M005 |
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC | da948ef3-3709-4bfc-9d17-f6f1ea325343 | 2025-12-04 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103951 | tolnaftate 1 % Topical Cream | PSN | 3abfd734-229b-1a0e-e054-00144ff88e88 | 5 |
| 103951 | tolnaftate 10 MG/ML Topical Cream | SCD | 3abfd734-229b-1a0e-e054-00144ff88e88 | 5 |
| 103951 | tolnaftate 1 % Topical Cream | SY | 3abfd734-229b-1a0e-e054-00144ff88e88 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-152-01 | 68016015201 | 1 TUBE in 1 BOX (68016-152-01) / 28 g in 1 TUBE | 1 tube | 2016-08-31 | 0000-00-00 | No | No | Current |