Povidone-Iodine
- Product NDC
- 53329-941
- 11-digit product format
- 533290941
- Labeler code
- 53329
- Product ID
- 53329-941_41d5b217-3e40-1229-e063-6394a90ae37c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone-Iodine
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M003
- 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
- 2026-12-31
- 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 | 53329-941 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 53329-941 | 53329-941-30 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-941-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-941-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-941-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-941-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-941-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-941-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-941-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-941-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-941-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-941-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-941-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-941-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Prep Pads Medium
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 797730 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 28c05c5c-09d3-2c62-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 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 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-941-09 | Povidone-IodinePrep Pads Medium | 1 mL in 1 PACKET | CLOTH | 1 | 10 | |
| 53329-941-30 | Povidone-IodinePrep Pads Medium | 100 in 1 BOX | CLOTH | 100 | 10 | |
| 53329-941-30 | Povidone-IodinePrep Pads Medium | 100 in 1 BOX | SWAB | 100 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-941 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241101_dec92845-e713-42a3-83a7-3a48920b7eed.zip |
| 53329-941 | PHYSICIAN EZ USE JOINT TUNNEL AND TRIGGER KIT (AMMONIA, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.] | 11 | Current NDC, Legacy NDC | 20241008_e25cfc22-29ba-473f-88c4-3c88e9f6863b.zip |
| 53329-941 | POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) CLOTH POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) CLOTH [MEDLINE INDUSTRIES, LP] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241212_28c05c5c-09d3-2c62-e054-00144ff8d46c.zip |
| 53329-941 | 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, 1 package rows | 20110826_f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac.zip |
| 53329-941 | PHYSICIAN EZ USE JOINT TUNNEL AND TRIGGER KIT II (LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.] | 3 | Current NDC, Legacy NDC | 20241008_0d2d52ef-ff21-4b28-b8ae-6a46570f7a74.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 10 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 10 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 10 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 10 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 10 |
| 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 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 33f08f03-93fb-214d-e063-6394a90a73bd | 1 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 33f08f03-93fb-214d-e063-6394a90a73bd | 1 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 33f08f03-93fb-214d-e063-6394a90a73bd | 1 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 33f08f03-93fb-214d-e063-6394a90a73bd | 1 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 33f08f03-93fb-214d-e063-6394a90a73bd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-941-09 | 53329094109 | 1 mL in 1 PACKET (53329-941-09) | 1 ml | 2007-01-01 | 0000-00-00 | No | No | Current |
| 53329-941-30 | 53329094130 | 100 PACKET in 1 BOX (53329-941-30) / 1 mL in 1 PACKET (53329-941-09) | 100 packet | 2019-01-11 | 0000-00-00 | No | No | Current |