Povidone-Iodine Gel
- Product NDC
- 65517-0070
- 11-digit product format
- 655170070
- Labeler code
- 65517
- Product ID
- 65517-0070_43f8fa10-9266-a4f3-e063-6394a90a9e93
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone-Iodine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Dukal LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-21
- Substance
- POVIDONE-IODINE
- Active strength
- 1 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Povidone-Iodine Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POVIDONE-IODINE | 1 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 85H0HZU99M |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65517-0070-1 | Povidone-Iodine Gel | 29.5 mL in 1 POUCH | GEL | 29.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65517-0070 | POVIDONE-IODINE GEL (POVIDONE-IODINE) GEL [DUKAL LLC] | 1 | Current NDC, 1 package rows | 20250122_2bebe082-59b6-17c1-e063-6294a90a9a52.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65517-0070-1 | 65517007001 | 29.5 mL in 1 POUCH (65517-0070-1) | 29.5 ml | 2025-01-21 | No | No | Current |