Premier Value Antifungal
- Product NDC
- 68016-474
- 11-digit product format
- 680160474
- Labeler code
- 68016
- Product ID
- 68016-474_49f1dae5-2b13-47e8-9a1a-cf6cbf834400
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Undecylenic Acid
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- PHARMACY VALUE ALLIANCE, LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-04-10
- Substance
- UNDECYLENIC ACID
- Active strength
- 25 mg/30mL
- 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
- Premier Value Antifungal
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 25 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f5694ee5-616c-40f6-8da4-c3620dbcd6f7 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-474-00 | Premier Value AntifungalMaximum Strength | 30 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-474-00 | ML - Milliliter | 68016-474 | 230bf601-f1d0-469d-81e8-afd04c64b3fb | 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 |
|---|---|---|---|---|---|---|
| ProClearz Maximum Strength Fungal Shield Brush-on Antifungal | TOLNAFTATE | Rooftop Consumer Health, Inc. | 4d451e87-c25b-49cf-92b8-747b053930c2 | 2026-03-02 | Warnings | M005 |
| HAND SANITIZER lsland Coconut | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf3a822-27d2-efef-e063-6294a90a0502 | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cherry Blossom | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf48a93-345d-b901-e063-6394a90ab41b | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cucumber Melon | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf552a4-b8b3-6fe3-e063-6394a90a722a | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Watermelon Sugar | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf57b6e-c271-b4c6-e063-6394a90a63c6 | 2026-03-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | e0a2a907-9c3a-4c4e-e053-2995a90abb91 | 2026-03-01 | Warnings | M005 |
| FOLUPIA FUNGAL NAIL RENEWAL | FOLUPIA FUNGAL NAIL RENEWAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4bcacd53-9446-67ec-e063-6294a90a209e | 2026-02-27 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | d6f5c6b5-5e56-462f-8c47-7986ce53669d | 2026-02-25 | Warnings | M005 |
| Lakeim FUNGAL NAIL RENEWAL Kit | FUNGAL NAIL RENEWAL KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b6aae50-b219-beee-e063-6394a90ab415 | 2026-02-22 | Warnings | M005 |
| Hermon Jock Itch spray. | MICONAZOLE NITRATE 2% | Beautivity LLC | 4b633528-667a-f34e-e063-6294a90a2b3d | 2026-02-21 | Warnings | M005 |
| Lakeim Fungal Nail Repair Pen | FUNGAL NAIL REPAIR PEN | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b23c3a6-51da-7875-e063-6394a90a1467 | 2026-02-18 | Warnings | M005 |
| OSIMOON FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b113f31-1a82-a3ca-e063-6394a90a3231 | 2026-02-17 | Warnings | M005 |
| Hermon Ringworm Antifungal soap. | CLOTRIMAZOLE 1% | Beautivity LLC | 48405a7c-14cd-b3a0-e063-6394a90a9fc9 | 2026-02-13 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal soap. | TEA TREE OIL ANTIFUNGAL SOAP | RoyceDerm LLC | 3a6d1e32-a38b-3dde-e063-6394a90a88f3 | 2026-02-13 | Warnings | M005 |
| Happy Nuts Jock Itch Powder | MICONAZOLE NITRATE | Suit Up Brands LLC | 42e2d9df-6537-b3a1-e063-6394a90a47b7 | 2026-02-13 | Warnings | M005 |
| Nail Antifungal Treatment | TOLNAFTATE 1% FUNGI NAIL | BENM INC. | 2ea24785-c648-4104-e063-6294a90ab12f | 2026-02-12 | Warnings | M005 |
| Hermon Ringworm Treatment Kit | MICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1% | Beautivity LLC | 4a9d9c6e-0e0f-d539-e063-6294a90acb57 | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Antifungal Soothing Cream | ANTIFUNGAL SOOTHING CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a077685-4177-bc0d-e063-6294a90a461b | 2026-02-12 | Warnings | M005 |
| PHARMBANNER FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a08ec6c-03ae-b9e5-e063-6394a90a0afb | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Tinea Versicolor Cream | TINEA VERSICOLOR CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a095194-c7ea-7f30-e063-6294a90a7ea1 | 2026-02-12 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-474-00 | 68016047400 | 30 mL in 1 BOTTLE, WITH APPLICATOR (68016-474-00) | 30 ml | 2019-04-10 | 0000-00-00 | No | No | Current |