FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Product NDC
52380-0126
11-digit product format
523800126
Labeler code
52380
Product ID
52380-0126_eb506ab1-18ea-63a1-e053-2995a90a5bfd
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aplicare Products, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-31
Marketing end
2025-08-31
Substance
POVIDONE-IODINE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52380-0126DDiscontinued by firm2026-10-05
excluded packagepackage52380-012652380-0126-2DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0126-2GM - Gram52380-012691378eff-90d7-4a0b-b303-06dfab0c036912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0126APLICARE POVIDONE-IODINE (POVIDONE-IODINE) OINTMENT [APLICARE PRODUCTS, LLC]5Legacy NDC20230217_c6190453-4385-4be5-b4b9-4637b4e84845.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-0126-2523800126021 g in 1 PACKET (52380-0126-2) 1 g2017-05-310000-00-00NoNoCurrent