Aplicare Povidone-iodine Scrub

Product NDC
52380-4802
Requested package NDC
52380-4802-8
11-digit product format
523804802
Labeler code
52380
Product ID
52380-4802_5a8748b6-17b0-cdca-e063-6394a90ad140
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
1998-01-01
Substance
POVIDONE-IODINE
Active strength
7.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52380-480252380-4802-8IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Aplicare Povidone-iodine Scrub
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE7.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314188Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8a23a29-2541-4987-a534-17a6369a6c8dAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-4802-8Aplicare Povidone-iodine Scrub118 mL in 1 BOTTLE, PLASTICSOLUTION11814

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-4802APLICARE POVIDONE-IODINE SCRUB (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]13Current NDC, Legacy NDC, 1 package rows20240110_b8a23a29-2541-4987-a534-17a6369a6c8d.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-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsExact identifier
ndc (package): 52380-4802-8
ndc (product): 52380-4802
ndc11 (package): 52380480208

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314188povidone-iodine 7.5 % Topical SolutionPSNb8a23a29-2541-4987-a534-17a6369a6c8d14
314188povidone-iodine 75 MG/ML Topical SolutionSCDb8a23a29-2541-4987-a534-17a6369a6c8d14
314188povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SolutionSYb8a23a29-2541-4987-a534-17a6369a6c8d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-4802-852380480208118 mL in 1 BOTTLE, PLASTIC (52380-4802-8) 118 ml1998-01-010000-00-00NoNoCurrent