FDA.reportPublic FDA data

Aplicare

Product NDC
52380-0138
11-digit product format
523800138
Labeler code
52380
Product ID
52380-0138_4640ae81-0ef8-0677-e063-6394a90a5a89
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Aplicare Products LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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
1300277Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a48b8ef-f2d6-ed50-e063-6394a90a8ebeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0138-1Aplicare1 in 1 POUCHSWAB13
52380-0138-1Aplicare2.4 mL in 1 APPLICATORSWAB2.43
52380-0138-2Aplicare1 in 1 POUCHSWAB13
52380-0138-2Aplicare50 in 1 BOXSWAB503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0138APLICARE (POVIDONE-IODINE) SWAB [APLICARE PRODUCTS LLC]2Current NDC, 4 package rows20240907_0a48b8ef-f2d6-ed50-e063-6394a90a8ebe.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
AplicarePOVIDONE-IODINEAplicare Products LLC0a48b8ef-f2d6-ed50-e063-6394a90a8ebe2025-12-18WarningsExact identifier
ndc (product): 52380-0138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300277povidone-iodine gel 10 % Medicated PadPSN0a48b8ef-f2d6-ed50-e063-6394a90a8ebe3
1300277povidone-iodine 0.1 MG/MG Medicated PadSCD0a48b8ef-f2d6-ed50-e063-6394a90a8ebe3
1300277povidone-iodine 10 % (titratable iodine 1 % ) Gel SwabstickSY0a48b8ef-f2d6-ed50-e063-6394a90a8ebe3
1300277povidone-iodine 10 % Gel SwabstickSY0a48b8ef-f2d6-ed50-e063-6394a90a8ebe3
1300277povidone-iodine 10 % SwabstickSY0a48b8ef-f2d6-ed50-e063-6394a90a8ebe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52380-0138-1523800138011 APPLICATOR in 1 POUCH (52380-0138-1) / 2.4 mL in 1 APPLICATOR1 applicator2024-09-01NoNoCurrent
52380-0138-25238001380250 POUCH in 1 BOX (52380-0138-2) / 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR50 pouch2024-09-01NoNoCurrent