FDA.reportPublic FDA data

PVP Iodine Prep Swabstick

Product NDC
10819-3885
11-digit product format
108193885
Labeler code
10819
Product ID
10819-3885_40ab78fb-f19d-ce27-e063-6294a90ae51d
Type
HUMAN OTC DRUG
Nonproprietary name
providone iodine
Dosage form
STICK
Route
TOPICAL
Labeler
Professional Disposables International, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1978-01-01
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
PVP Iodine Prep Swabstick
Brand name suffix
Ones and Threes
Listing expiration
2026-12-31

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
10819-3885-1PVP Iodine Prep SwabstickOnes and Threes2.5 mL in 1 PACKETSTICK2.512
10819-3885-1PVP Iodine Prep SwabstickOnes and Threes50 in 1 BOXSTICK5012
10819-3885-2PVP Iodine Prep SwabstickOnes and Threes25 in 1 BOXSTICK2512
10819-3885-2PVP Iodine Prep SwabstickOnes and Threes7 mL in 1 PACKETSTICK712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPVP IODINE PREP PAD MEDIUM AND LARGE (PROVIDONE IODINE) SWAB PVP IODINE PREP SWABSTICK ONES AND THREES (PROVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]3
IODINEACTIVE MOIETY9679TC07X4PVP IODINE PREP PAD MEDIUM AND LARGE (PROVIDONE IODINE) SWAB PVP IODINE PREP SWABSTICK ONES AND THREES (PROVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPVP IODINE PREP PAD MEDIUM AND LARGE (PROVIDONE IODINE) SWAB PVP IODINE PREP SWABSTICK ONES AND THREES (PROVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPVP IODINE PREP PAD MEDIUM AND LARGE (PROVIDONE IODINE) SWAB PVP IODINE PREP SWABSTICK ONES AND THREES (PROVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-3885PVP IODINE PREP PAD MEDIUM AND LARGE (PROVIDONE IODINE) SWAB PVP IODINE PREP SWABSTICK ONES AND THREES (PROVIDONE IODINE) STICK [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]10Current NDC, Legacy NDC, 4 package rows20240823_50c524ab-7029-494a-8bb4-d90a4d184fb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN50c524ab-7029-494a-8bb4-d90a4d184fb212
797730povidone-iodine 100 MG/ML Medicated PadSCD50c524ab-7029-494a-8bb4-d90a4d184fb212
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY50c524ab-7029-494a-8bb4-d90a4d184fb212
797730povidone-iodine 10 % Medicated PadSY50c524ab-7029-494a-8bb4-d90a4d184fb212
797730povidone-iodine 10 % Medicated SwabstickSY50c524ab-7029-494a-8bb4-d90a4d184fb212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10819-3885-11081938850150 PACKET in 1 BOX (10819-3885-1) / 2.5 mL in 1 PACKET50 packet1978-01-012026-07-03NoNoCurrent
10819-3885-21081938850225 PACKET in 1 BOX (10819-3885-2) / 7 mL in 1 PACKET25 packet1978-01-012026-07-03NoNoCurrent