Tolnaftate 1% Antifungal Soaps
- Product NDC
- 85158-002
- 11-digit product format
- 851580002
- Labeler code
- 85158
- Product ID
- 85158-002_5b7ced44-44cf-f613-e063-6394a90a599b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- SOAP
- Route
- TOPICAL
- Labeler
- Shenzhen Shangmei Tiantianbaodan E-commerce Co., Ltd
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-07
- Substance
- TOLNAFTATE
- Active strength
- 1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 85158-002 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 85158-002 | 85158-002-01 | D | Discontinued by firm | 2026-10-15 |
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 1% Antifungal Soaps
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLNAFTATE | 1 g/100g |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85158-002-01 | 85158000201 | 2 POUCH in 1 BOX (85158-002-01) / 120 g in 1 POUCH | 2 pouch | 2026-09-10 | No | No | Current |