FDA.reportPublic FDA data

Aplicare

Product NDC
52380-0946
11-digit product format
523800946
Labeler code
52380
Product ID
52380-0946_4640ba32-cf35-18ad-e063-6394a90a4592
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
2024-09-27
Substance
POVIDONE-IODINE
Active strength
10 mg/g
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/g

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b3e4f14-e9e6-2f2e-e063-6394a90ab2e1Available 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
52380-0946-3Aplicare2 g in 1 APPLICATORSWAB23
52380-0946-3Aplicare3 in 1 PACKETSWAB33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0946APLICARE (POVIDONE IODINE) SWAB [APLICARE PRODUCTS LLC]2Current NDC, 2 package rows20240929_0b3e4f14-e9e6-2f2e-e063-6394a90ab2e1.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 LLC0b3e4f14-e9e6-2f2e-e063-6394a90ab2e12025-12-18WarningsExact identifier
ndc (product): 52380-0946

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN0b3e4f14-e9e6-2f2e-e063-6394a90ab2e13
797730povidone-iodine 100 MG/ML Medicated PadSCD0b3e4f14-e9e6-2f2e-e063-6394a90ab2e13
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY0b3e4f14-e9e6-2f2e-e063-6394a90ab2e13
797730povidone-iodine 10 % Medicated PadSY0b3e4f14-e9e6-2f2e-e063-6394a90ab2e13
797730povidone-iodine 10 % Medicated SwabstickSY0b3e4f14-e9e6-2f2e-e063-6394a90ab2e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52380-0946-3523800946033 APPLICATOR in 1 PACKET (52380-0946-3) / 2 g in 1 APPLICATOR3 applicator2024-09-27NoNoCurrent