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 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
31d08e09-181b-3a7a-e063-6294a90aa757Available 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

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

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
Povidone-Iodine SwabstickPOVIDONE IODINEProfessional Disposables International, Inc.31d08e09-181b-3a7a-e063-6294a90aa7572026-02-17WarningsExact identifier
ndc (product): 10819-3800

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 packet2025-05-15NoNoCurrent
10819-3800-21081938000225 PACKET in 1 BOX (10819-3800-2) / 7 mL in 1 PACKET25 packet2025-05-15NoNoCurrent