FDA.reportPublic FDA data

Aplicare Povidone-iodine Triples

Product NDC
52380-5101
11-digit product format
523805101
Labeler code
52380
Product ID
52380-5101_d7c2cbc8-b128-de12-e053-2a95a90abbab
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52380-5101DDiscontinued by firm2026-10-12
excluded packagepackage52380-510152380-5101-1DDiscontinued by firm2026-10-12
excluded packagepackage52380-510152380-5101-2DDiscontinued by firm2026-10-12
excluded packagepackage52380-510152380-5101-3DDiscontinued by firm2026-10-12
excluded packagepackage52380-510152380-5101-5DDiscontinued by firm2026-10-12

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage52380-5101-3
excluded packagepackage52380-5101-5
excluded packagepackage52380-5101-1
excluded packagepackage52380-5101-2

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
52380-5101-3EA - Each52380-51013ebcfd2d-985a-47db-ba3e-ec3167c7677612017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-5101APLICARE POVIDONE-IODINE TRIPLES (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]6Legacy NDC20230804_c674b28c-2c8d-43a8-9d6c-ab710e404089.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-5101-152380510101250 PACKET in 1 CASE (52380-5101-1) > 6.5 mL in 1 PACKET250 packet2017-05-310000-00-00NoNoCurrent
52380-5101-25238051010225 PACKET in 1 BOX (52380-5101-2) > 6.5 mL in 1 PACKET25 packet2017-05-310000-00-00NoNoCurrent
52380-5101-3523805101036.5 mL in 1 PACKET (52380-5101-3) 6.5 ml2017-05-310000-00-00NoNoCurrent
52380-5101-552380510105500 PACKET in 1 CASE (52380-5101-5) > 6.5 mL in 1 PACKET500 packet2017-05-310000-00-00NoNoCurrent