Povidone-Iodine
- Product NDC
- 53329-939
- Requested package NDC
- 53329-939-08
- 11-digit product format
- 533290939
- Labeler code
- 53329
- Product ID
- 53329-939_5a2041f7-ae03-0415-e063-6394a90acc4f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone-Iodine
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-01-01
- Substance
- POVIDONE-IODINE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Povidone-Iodine
- Brand name suffix
- Topical Antiseptic
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POVIDONE-IODINE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85H0HZU99M | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312564 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c9036a83-22f5-4a09-b01c-7093d4192c19 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-939-04 | Povidone-IodineTopical Antiseptic | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 20 | |
| 53329-939-06 | Povidone-IodineTopical Antiseptic | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 20 | |
| 53329-939-08 | Povidone-IodineTopical Antiseptic | 237 mL in 1 BOTTLE, PLASTIC | SOLUTION | 237 | 20 | |
| 53329-939-13 | Povidone-IodineTopical Antiseptic | 59 mL in 1 BOTTLE, PLASTIC | SOLUTION | 59 | 20 | |
| 53329-939-23 | Povidone-IodineTopical Antiseptic | 946 mL in 1 BOTTLE, PLASTIC | SOLUTION | 946 | 20 | |
| 53329-939-25 | Povidone-IodineTopical Antiseptic | 3785 mL in 1 BOTTLE, PLASTIC | SOLUTION | 3785 | 20 | |
| 53329-939-69 | Povidone-IodineTopical Antiseptic | 88 mL in 1 BOTTLE, PLASTIC | SOLUTION | 88 | 20 | |
| 53329-939-06 | Povidone-IodineTopical Antiseptic | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 9 | |
| 53329-939-08 | Povidone-IodineTopical Antiseptic | 237 mL in 1 BOTTLE, PLASTIC | SOLUTION | 237 | 9 | |
| 53329-939-13 | Povidone-IodineTopical Antiseptic | 59 mL in 1 BOTTLE, PLASTIC | SOLUTION | 59 | 9 | |
| 53329-939-23 | Povidone-IodineTopical Antiseptic | 946 mL in 1 BOTTLE, PLASTIC | SOLUTION | 946 | 9 | |
| 53329-939-25 | Povidone-IodineTopical Antiseptic | 3785 mL in 1 BOTTLE, PLASTIC | SOLUTION | 3785 | 9 | |
| 53329-939-44 | Povidone-IodineTopical Antiseptic | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 9 | |
| 53329-939-69 | Povidone-IodineTopical Antiseptic | 88 mL in 1 BOTTLE, PLASTIC | SOLUTION | 88 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-939-04 | ML - Milliliter | 53329-939 | 5a920af1-27f5-4add-b44a-662e41d86caf | 1 | 2025-01-14 |
| 53329-939-13 | ML - Milliliter | 53329-939 | 696a7e34-e1c2-49c0-9d80-4dd1094f7945 | 1 | 2023-08-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-939 | POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, LP] | 20 | Current NDC, Legacy NDC, 7 package rows | 20240302_c9036a83-22f5-4a09-b01c-7093d4192c19.zip |
| 53329-939 | POVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.] | 9 | Current NDC, Legacy NDC, 7 package rows | 20110826_f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac.zip |
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 |
|---|---|---|---|---|---|---|
| Povidone-Iodine Topical Antiseptic | POVIDONE-IODINE | Medline Industries, LP | c9036a83-22f5-4a09-b01c-7093d4192c19 | 2026-08-28 | Warnings | 53329-939-08 53329-939 53329093908 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312564 | povidone-iodine 10 % Topical Solution | PSN | c9036a83-22f5-4a09-b01c-7093d4192c19 | 20 |
| 312564 | povidone-iodine 100 MG/ML Topical Solution | SCD | c9036a83-22f5-4a09-b01c-7093d4192c19 | 20 |
| 312564 | povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution | SY | c9036a83-22f5-4a09-b01c-7093d4192c19 | 20 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 312564 | povidone-iodine 10 % Topical Solution | PSN | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 617973 | povidone-iodine 10 % Topical Spray | PSN | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 312564 | povidone-iodine 100 MG/ML Topical Solution | SCD | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 617973 | povidone-iodine 100 MG/ML Topical Spray | SCD | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 312564 | povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution | SY | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
| 617973 | povidone-iodine 10 % Topical Spray | SY | f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-939-08 | 53329093908 | 237 mL in 1 BOTTLE, PLASTIC (53329-939-08) | 237 ml | 2007-01-01 | 0000-00-00 | No | No | Current |