Vite20
- Product NDC
- 63347-800
- 11-digit product format
- 633470800
- Labeler code
- 63347
- Product ID
- 63347-800_d6d98f0f-58dd-4fb8-9403-5ce47b071e29
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- UNDECYLENIC ACID
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Blaine Labs Inc.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-01
- Substance
- UNDECYLENIC ACID
- Active strength
- 2 mg/20mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 63347-800 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63347-800 | 63347-800-01 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
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
- Vite20
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 2 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 18f8ea1c-360e-43c0-98df-5816af4dec66 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63347-800-01 | 2022-02-21 | C162847 | 48780-1 | d6a99b39-37f8-a426-e053-dadaa90af4c2 | 18f8ea1c-360e-43c0-98df-5816af4dec66 |
| 63347-800-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-37f8-a426-e053-dadaa90af4c2 | 18f8ea1c-360e-43c0-98df-5816af4dec66 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63347-800-01 | Vite20 | 20 mL in 1 TUBE | CREAM | 20 | 5 |
DailyMed Socrata Ingredients#
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63347-800-01 | 63347080001 | 20 mL in 1 TUBE (63347-800-01) | 20 ml | 2012-02-01 | 0000-00-00 | No | No | Current |