FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Product NDC
52380-0011
Requested package NDC
52380-0011-3
11-digit product format
523800011
Labeler code
52380
Product ID
52380-0011_eb506ab1-190d-63a1-e053-2995a90a5bfd
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Aplicare Products, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-31
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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52380-001152380-0011-3DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
52380-0011-1Aplicare Povidone-Iodine30 mL in 1 PACKETSOLUTION3013
52380-0011-3Aplicare Povidone-Iodine22.5 mL in 1 PACKETSOLUTION22.513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0011-1ML - Milliliter52380-0011d51b0835-c89f-4fe4-8859-36c1b27d1a6712017-07-07
52380-0011-3ML - Milliliter52380-001108504a51-dc00-44b1-bfe2-207aa1beb2f612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0011APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]12Legacy NDC, 2 package rows20231019_b760668f-31be-47fa-9eee-38cb67780e21.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, LLCb760668f-31be-47fa-9eee-38cb67780e212025-11-07WarningsExact identifier
ndc (package): 52380-0011-3
ndc (product): 52380-0011
ndc11 (package): 52380001103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNb760668f-31be-47fa-9eee-38cb67780e2113
312564povidone-iodine 100 MG/ML Topical SolutionSCDb760668f-31be-47fa-9eee-38cb67780e2113
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYb760668f-31be-47fa-9eee-38cb67780e2113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-0011-35238000110322.5 mL in 1 PACKET (52380-0011-3) 22.5 ml2017-05-310000-00-00NoNoCurrent