Povidone-Iodine
- Product NDC
- 53329-940
- 11-digit product format
- 533290940
- Labeler code
- 53329
- Product ID
- 53329-940_e9bea3c8-bd76-7ad6-e053-2995a90aa985
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone-Iodine
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- part333E
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2007-01-01
- Marketing end
- 0000-00-00
- Substance
- POVIDONE-IODINE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 53329-940 | D | Discontinued by firm | 2026-10-05 | ||
| excluded product | product | 53329-940 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 53329-940 | 53329-940-09 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 53329-940 | 53329-940-97 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 53329-940 | 53329-940-97 | 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 product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-940-97 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-940-97 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-940-09 | 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 product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-940-97 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-940-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-940-97 | 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 product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-940-97 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-940-09 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-940-97 | 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 product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-940-97 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-940-09 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-940-97 | 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 product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-940-97 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-940-09 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-940-97 | 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 product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-940-97 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-940-09 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-940-97 | 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 product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-940-97 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-940-09 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-940-97 | 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 product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-940-97 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-940-09 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-940-97 | 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 product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-940-97 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-940-09 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-940-97 | 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 product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-940-97 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-940-97 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-940-09 | 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 product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-940-97 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-940-97 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-940-09 | 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 product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-940-97 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-940-97 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53329-940-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| 53329-940-09 | Povidone-IodinePrep Pads Medium Bulk | 1 mL in 1 PACKET | CLOTH | 1 | 10 | |
| 53329-940-97 | Povidone-IodinePrep Pads Medium Bulk | 3000 in 1 CASE | CLOTH | 3000 | 10 | |
| 53329-940-97 | Povidone-IodinePrep Pads Medium Bulk | 1 mL in 1 PACKET | CLOTH | 1 | 10 | |
| 53329-940-09 | Povidone-IodinePrep Pads Medium Bulk | 1 in 1 PACKET | SWAB | 1 | 9 | |
| 53329-940-97 | Povidone-IodinePrep Pads Medium Bulk | 3000 in 1 CASE | SWAB | 3000 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-940 | POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) CLOTH POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) CLOTH [MEDLINE INDUSTRIES, LP] | 9 | Legacy NDC, 3 package rows | 20241212_28c05c5c-09d3-2c62-e054-00144ff8d46c.zip |
| 53329-940 | 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 | Legacy NDC, 2 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 Prep Pads Medium | POVIDONE-IODINE | Medline Industries, LP | 28c05c5c-09d3-2c62-e054-00144ff8d46c | 2025-10-23 | Warnings | 53329-940 |
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-940-09 | 53329094009 | 1 mL in 1 PACKET (53329-940-09) | 1 ml | 2007-01-01 | 0000-00-00 | No | No | Current |
| 53329-940-97 | 53329094097 | 3000 PACKET in 1 CASE (53329-940-97) > 1 mL in 1 PACKET (53329-940-09) | 3000 packet | 2019-01-11 | 0000-00-00 | No | No | Current |