FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Product NDC
52380-1905
Requested package NDC
52380-1905-7
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52380-190552380-1905-7DDiscontinued by firm2026-10-05

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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Aplicare Povidone-Iodine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312564Internal RxNorm lookup
617973Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7302a2f8-a600-4200-bc4e-309e4c190fe5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-1905-0Aplicare Povidone-Iodine60 mL in 1 BOTTLE, SPRAYSOLUTION6018
52380-1905-2Aplicare Povidone-Iodine60 mL in 1 BOTTLESOLUTION6018
52380-1905-3Aplicare Povidone-Iodine90 mL in 1 BOTTLESOLUTION9018
52380-1905-4Aplicare Povidone-Iodine120 mL in 1 BOTTLESOLUTION12018
52380-1905-6Aplicare Povidone-Iodine480 mL in 1 BOTTLESOLUTION48018
52380-1905-7Aplicare Povidone-Iodine960 mL in 1 BOTTLESOLUTION96018
52380-1905-8Aplicare Povidone-Iodine240 mL in 1 BOTTLESOLUTION24018
52380-1905-9Aplicare Povidone-Iodine3800 mL in 1 BOTTLESOLUTION380018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-1905-0ML - Milliliter52380-1905712f4860-73a5-4627-acea-455ac394f12f12012-07-24
52380-1905-2ML - Milliliter52380-1905865096b9-06c0-4359-8597-be462a1cfe2212012-07-24
52380-1905-4ML - Milliliter52380-19051f55cb39-ca3a-4ea3-9c93-46d3b7e8f6ce12012-07-24
52380-1905-6ML - Milliliter52380-1905c5cf32e5-a122-4909-938d-a2be489b2b8112012-07-24
52380-1905-7ML - Milliliter52380-1905f43064fa-189c-446f-8ec6-2b2620d74e2912012-07-24
52380-1905-8ML - Milliliter52380-1905fa272fa7-ef75-49e7-9148-7ac22bd1cb5112012-07-24
52380-1905-9ML - Milliliter52380-190565df94e9-1ee3-42e9-91ae-04b9bf544a7312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
IODINEACTIVE MOIETY9679TC07X4APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RAPLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-1905APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]17Current NDC, Legacy NDC, 8 package rows20240110_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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsExact identifier
ndc (package): 52380-1905-7
ndc (product): 52380-1905
ndc11 (package): 52380190507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN7302a2f8-a600-4200-bc4e-309e4c190fe518
617973povidone-iodine 10 % Topical SprayPSN7302a2f8-a600-4200-bc4e-309e4c190fe518
312564povidone-iodine 100 MG/ML Topical SolutionSCD7302a2f8-a600-4200-bc4e-309e4c190fe518
617973povidone-iodine 100 MG/ML Topical SpraySCD7302a2f8-a600-4200-bc4e-309e4c190fe518
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY7302a2f8-a600-4200-bc4e-309e4c190fe518
617973povidone-iodine 10 % Topical SpraySY7302a2f8-a600-4200-bc4e-309e4c190fe518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-1905-752380190507960 mL in 1 BOTTLE (52380-1905-7) 960 ml1998-09-012022-03-31NoNoCurrent