FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Product NDC
52380-1905
11-digit product format
523801905
Labeler code
52380
Product ID
52380-1905_4640bac3-a3f1-ba7f-e063-6294a90a66ea
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aplicare Povidone-Iodine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564, 617973

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

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
52380-1905-05238019050060 mL in 1 BOTTLE, SPRAY (52380-1905-0) 60 ml1998-09-010000-00-00NoNoCurrent
52380-1905-25238019050260 mL in 1 BOTTLE (52380-1905-2) 60 ml1998-09-012022-11-06NoNoCurrent
52380-1905-35238019050390 mL in 1 BOTTLE (52380-1905-3) 90 ml1998-09-010000-00-00NoNoCurrent
52380-1905-452380190504120 mL in 1 BOTTLE (52380-1905-4) 120 ml1998-09-012022-11-06NoNoCurrent
52380-1905-652380190506480 mL in 1 BOTTLE (52380-1905-6) 480 ml1998-09-012022-11-06NoNoCurrent
52380-1905-752380190507960 mL in 1 BOTTLE (52380-1905-7) 960 ml1998-09-010000-00-00NoNoCurrent
52380-1905-852380190508240 mL in 1 BOTTLE (52380-1905-8) 240 ml1998-09-012022-06-01NoNoCurrent
52380-1905-9523801905093800 mL in 1 BOTTLE (52380-1905-9) 3800 ml1998-09-012022-06-01NoNoCurrent