Povidone Iodine Impregnated
- Product NDC
- 34645-1031
- 11-digit product format
- 346451031
- Labeler code
- 34645
- Product ID
- 34645-1031_085eab46-3c0c-cf27-e063-6294a90a30fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone Iodine
- Dosage form
- SPONGE
- Route
- TOPICAL
- Labeler
- Jianerkang Medical Co., Ltd
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-03-03
- Substance
- POVIDONE-IODINE
- Active strength
- 7.5 mg/mL
- 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 Impregnated
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POVIDONE-IODINE | 7.5 mg/mL |
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 |
|---|
| 34645-1031-1 | Povidone Iodine Impregnated | 10 in 1 BOX | SPONGE | 10 | | 4 |
| 34645-1031-1 | Povidone Iodine Impregnated | 120 mL in 1 POUCH | SPONGE | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 34645-1031 | POVIDONE IODINE IMPREGNATED (POVIDONE IODINE) SPONGE [JIANERKANG MEDICAL CO., LTD] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231024_5a33ec74-1e65-4f16-a8f7-230d7e818dbd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 34645-1031-1 | 34645103101 | 10 POUCH in 1 BOX (34645-1031-1) / 120 mL in 1 POUCH | 10 pouch | 2015-03-03 | 0000-00-00 | No | No | Current |