FDA.reportPublic FDA data

Povidone-Iodine Swabstick

Product NDC
10819-3800
11-digit product format
108193800
Labeler code
10819
Product ID
10819-3800_4b062bc1-2599-775d-e063-6294a90a4582
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
STICK
Route
TOPICAL
Labeler
Professional Disposables International, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-15
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Povidone-Iodine Swabstick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui797730

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-3800-1Povidone-Iodine Swabstick2.5 mL in 1 PACKETSTICK2.53
10819-3800-1Povidone-Iodine Swabstick50 in 1 BOXSTICK503
10819-3800-2Povidone-Iodine Swabstick7 mL in 1 PACKETSTICK73
10819-3800-2Povidone-Iodine Swabstick25 in 1 BOXSTICK253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-3800POVIDONE-IODINE SWABSTICK (POVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]1Current NDC, 4 package rows20250516_31d08e09-181b-3a7a-e063-6294a90aa757.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN31d08e09-181b-3a7a-e063-6294a90aa7573
797730povidone-iodine 100 MG/ML Medicated PadSCD31d08e09-181b-3a7a-e063-6294a90aa7573
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY31d08e09-181b-3a7a-e063-6294a90aa7573
797730povidone-iodine 10 % Medicated PadSY31d08e09-181b-3a7a-e063-6294a90aa7573
797730povidone-iodine 10 % Medicated SwabstickSY31d08e09-181b-3a7a-e063-6294a90aa7573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10819-3800-11081938000150 PACKET in 1 BOX (10819-3800-1) / 2.5 mL in 1 PACKET50 packet2025-05-15NoNoHistorical
10819-3800-21081938000225 PACKET in 1 BOX (10819-3800-2) / 7 mL in 1 PACKET25 packet2025-05-15NoNoHistorical