FDA.reportPublic FDA data

Povidone-Iodine

Product NDC
53329-946
11-digit product format
533290946
Labeler code
53329
Product ID
53329-946_41d9ef88-7de7-a717-e063-6394a90a4c29
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
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
Povidone-Iodine
Brand name suffix
Swabsticks Triples
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
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
53329-946-02Povidone-IodineSwabsticks Triples3 in 1 PACKETSWAB39
53329-946-75Povidone-IodineSwabsticks Triples25 in 1 BOXSWAB259
53329-946-02Povidone-IodineSwabsticks Triples3 mL in 1 PACKETSWAB38
53329-946-75Povidone-IodineSwabsticks Triples25 in 1 BOXSWAB258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-946-02EA - Each53329-9465a7ce3ac-8285-4f38-acde-a7895688cb2b12019-07-02
53329-946-75EA - Each53329-946a4b6d21b-1b76-4a3e-9702-f8c489de93a712019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Povidone-IodineACTIVE INGREDIENT85H0HZU99MPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
IodineACTIVE MOIETY9679TC07X4POVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
Citric AcidINACTIVE INGREDIENT2968PHW8QPPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9
WaterINACTIVE INGREDIENT059QF0KO0RPOVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-946POVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM (POVIDONE-IODINE) SWAB POVIDONE-IODINE PREP PADS MEDIUM BULK (POVIDONE-IODINE) SWAB POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION PREP SOLUTION WITH SPRAY BOTTLE (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20110826_f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac.zip
53329-946POVIDONE-IODINE SWABSTICKS SINGLES (POVIDONE-IODINE) SWAB POVIDONE-IODINE SWABSTICKS TRIPLES (POVIDONE-IODINE) SWAB [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 2 package rows20241213_28c26a44-0699-4fa5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
312564povidone-iodine 10 % Topical SolutionPSNf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
617973povidone-iodine 10 % Topical SprayPSNf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
797730povidone-iodine 100 MG/ML Medicated PadSCDf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
312564povidone-iodine 100 MG/ML Topical SolutionSCDf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
617973povidone-iodine 100 MG/ML Topical SpraySCDf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
797730povidone-iodine 10 % Medicated PadSYf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
797730povidone-iodine 10 % Medicated SwabstickSYf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
617973povidone-iodine 10 % Topical SpraySYf1b4f6fd-2806-4273-8c72-e7c3d5bca4ac9
797730povidone-iodine 10 % Medicated PadPSN28c26a44-0699-4fa5-e054-00144ff88e888
797730povidone-iodine 100 MG/ML Medicated PadSCD28c26a44-0699-4fa5-e054-00144ff88e888
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY28c26a44-0699-4fa5-e054-00144ff88e888
797730povidone-iodine 10 % Medicated PadSY28c26a44-0699-4fa5-e054-00144ff88e888
797730povidone-iodine 10 % Medicated SwabstickSY28c26a44-0699-4fa5-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-946-02533290946023 mL in 1 PACKET (53329-946-02) 3 ml2007-01-010000-00-00NoNoCurrent
53329-946-755332909467525 PACKET in 1 BOX (53329-946-75) / 3 mL in 1 PACKET (53329-946-02) 25 packet2018-12-120000-00-00NoNoCurrent