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

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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui1300277

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

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