FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Product NDC
52380-0011
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52380-0011DDiscontinued by firm2026-11-12
excluded packagepackage52380-001152380-0011-1DDiscontinued by firm2026-11-12
excluded packagepackage52380-001152380-0011-3DDiscontinued by firm2026-11-12

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52380-001152380-0011-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

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
52380-0011-15238000110130 mL in 1 PACKET (52380-0011-1) 30 ml2017-05-310000-00-00NoNoCurrent
52380-0011-35238000110322.5 mL in 1 PACKET (52380-0011-3) 22.5 ml2017-05-310000-00-00NoNoCurrent