Aplicare Povidone-Iodine
- Product NDC
- 52380-1905
- 11-digit product format
- 523801905
- Labeler code
- 52380
- Product ID
- 52380-1905_5a86eb3c-9bed-842f-e063-6294a90adff3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Povidone-Iodine
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Aplicare Products, LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-09-01
- Substance
- POVIDONE-IODINE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 package | package | 52380-1905 | 52380-1905-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 52380-1905 | 52380-1905-4 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 52380-1905 | 52380-1905-6 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 52380-1905 | 52380-1905-7 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 52380-1905 | 52380-1905-8 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 52380-1905 | 52380-1905-9 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 52380-1905-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 52380-1905-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 52380-1905-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 52380-1905-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 52380-1905-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 52380-1905-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-9 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 52380-1905-4 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-7 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 52380-1905-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-7 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 52380-1905-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-9 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-7 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 52380-1905-4 | ad56d346431e… | cc804d4bbf1e… |
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
- Aplicare Povidone-Iodine
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 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 |
|---|---|---|---|---|---|---|
| 52380-1905-0 | Aplicare Povidone-Iodine | 60 mL in 1 BOTTLE, SPRAY | SOLUTION | 60 | 18 | |
| 52380-1905-2 | Aplicare Povidone-Iodine | 60 mL in 1 BOTTLE | SOLUTION | 60 | 18 | |
| 52380-1905-3 | Aplicare Povidone-Iodine | 90 mL in 1 BOTTLE | SOLUTION | 90 | 18 | |
| 52380-1905-4 | Aplicare Povidone-Iodine | 120 mL in 1 BOTTLE | SOLUTION | 120 | 18 | |
| 52380-1905-6 | Aplicare Povidone-Iodine | 480 mL in 1 BOTTLE | SOLUTION | 480 | 18 | |
| 52380-1905-7 | Aplicare Povidone-Iodine | 960 mL in 1 BOTTLE | SOLUTION | 960 | 18 | |
| 52380-1905-8 | Aplicare Povidone-Iodine | 240 mL in 1 BOTTLE | SOLUTION | 240 | 18 | |
| 52380-1905-9 | Aplicare Povidone-Iodine | 3800 mL in 1 BOTTLE | SOLUTION | 3800 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52380-1905-0 | ML - Milliliter | 52380-1905 | 712f4860-73a5-4627-acea-455ac394f12f | 1 | 2012-07-24 |
| 52380-1905-2 | ML - Milliliter | 52380-1905 | 865096b9-06c0-4359-8597-be462a1cfe22 | 1 | 2012-07-24 |
| 52380-1905-4 | ML - Milliliter | 52380-1905 | 1f55cb39-ca3a-4ea3-9c93-46d3b7e8f6ce | 1 | 2012-07-24 |
| 52380-1905-6 | ML - Milliliter | 52380-1905 | c5cf32e5-a122-4909-938d-a2be489b2b81 | 1 | 2012-07-24 |
| 52380-1905-7 | ML - Milliliter | 52380-1905 | f43064fa-189c-446f-8ec6-2b2620d74e29 | 1 | 2012-07-24 |
| 52380-1905-8 | ML - Milliliter | 52380-1905 | fa272fa7-ef75-49e7-9148-7ac22bd1cb51 | 1 | 2012-07-24 |
| 52380-1905-9 | ML - Milliliter | 52380-1905 | 65df94e9-1ee3-42e9-91ae-04b9bf544a73 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| NONOXYNOL-9 | INACTIVE INGREDIENT | 48Q180SH9T | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.] | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52380-1905 | APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC] | 17 | Current NDC, Legacy NDC, 8 package rows | 20240110_7302a2f8-a600-4200-bc4e-309e4c190fe5.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 |
|---|---|---|---|---|---|---|
| Aplicare Povidone-Iodine | POVIDONE-IODINE | Aplicare Products, LLC | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 2026-09-02 | Warnings | 52380-1905 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312564 | povidone-iodine 10 % Topical Solution | PSN | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
| 617973 | povidone-iodine 10 % Topical Spray | PSN | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
| 312564 | povidone-iodine 100 MG/ML Topical Solution | SCD | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
| 617973 | povidone-iodine 100 MG/ML Topical Spray | SCD | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
| 312564 | povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution | SY | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
| 617973 | povidone-iodine 10 % Topical Spray | SY | 7302a2f8-a600-4200-bc4e-309e4c190fe5 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52380-1905-0 | 52380190500 | 60 mL in 1 BOTTLE, SPRAY (52380-1905-0) | 60 ml | 1998-09-01 | 0000-00-00 | No | No | Current |
| 52380-1905-2 | 52380190502 | 60 mL in 1 BOTTLE (52380-1905-2) | 60 ml | 1998-09-01 | 2022-11-06 | No | No | Current |
| 52380-1905-3 | 52380190503 | 90 mL in 1 BOTTLE (52380-1905-3) | 90 ml | 1998-09-01 | 0000-00-00 | No | No | Current |
| 52380-1905-4 | 52380190504 | 120 mL in 1 BOTTLE (52380-1905-4) | 120 ml | 1998-09-01 | 2022-11-06 | No | No | Current |
| 52380-1905-6 | 52380190506 | 480 mL in 1 BOTTLE (52380-1905-6) | 480 ml | 1998-09-01 | 2022-11-06 | No | No | Current |
| 52380-1905-7 | 52380190507 | 960 mL in 1 BOTTLE (52380-1905-7) | 960 ml | 1998-09-01 | 0000-00-00 | No | No | Current |
| 52380-1905-8 | 52380190508 | 240 mL in 1 BOTTLE (52380-1905-8) | 240 ml | 1998-09-01 | 2022-06-01 | No | No | Current |
| 52380-1905-9 | 52380190509 | 3800 mL in 1 BOTTLE (52380-1905-9) | 3800 ml | 1998-09-01 | 2022-06-01 | No | No | Current |