FDA.reportPublic FDA data

Povidone-Iodine

Product NDC
53329-939
11-digit product format
533290939
Labeler code
53329
Product ID
53329-939_129c8b5c-88ca-c276-e063-6294a90a993f
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SOLUTION
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
Topical Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

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
53329-939-04Povidone-IodineTopical Antiseptic118 mL in 1 BOTTLE, PLASTICSOLUTION11820
53329-939-06Povidone-IodineTopical Antiseptic473 mL in 1 BOTTLE, PLASTICSOLUTION47320
53329-939-08Povidone-IodineTopical Antiseptic237 mL in 1 BOTTLE, PLASTICSOLUTION23720
53329-939-13Povidone-IodineTopical Antiseptic59 mL in 1 BOTTLE, PLASTICSOLUTION5920
53329-939-23Povidone-IodineTopical Antiseptic946 mL in 1 BOTTLE, PLASTICSOLUTION94620
53329-939-25Povidone-IodineTopical Antiseptic3785 mL in 1 BOTTLE, PLASTICSOLUTION378520
53329-939-69Povidone-IodineTopical Antiseptic88 mL in 1 BOTTLE, PLASTICSOLUTION8820
53329-939-06Povidone-IodineTopical Antiseptic473 mL in 1 BOTTLE, PLASTICSOLUTION4739
53329-939-08Povidone-IodineTopical Antiseptic237 mL in 1 BOTTLE, PLASTICSOLUTION2379
53329-939-13Povidone-IodineTopical Antiseptic59 mL in 1 BOTTLE, PLASTICSOLUTION599
53329-939-23Povidone-IodineTopical Antiseptic946 mL in 1 BOTTLE, PLASTICSOLUTION9469
53329-939-25Povidone-IodineTopical Antiseptic3785 mL in 1 BOTTLE, PLASTICSOLUTION37859
53329-939-44Povidone-IodineTopical Antiseptic118 mL in 1 BOTTLE, PLASTICSOLUTION1189
53329-939-69Povidone-IodineTopical Antiseptic88 mL in 1 BOTTLE, PLASTICSOLUTION889

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-939POVIDONE-IODINE TOPICAL ANTISEPTIC (POVIDONE-IODINE) SOLUTION [MEDLINE INDUSTRIES, LP]20Current NDC, Legacy NDC, 7 package rows20240302_c9036a83-22f5-4a09-b01c-7093d4192c19.zip
53329-939POVIDONE-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, 7 package rows20110826_f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNc9036a83-22f5-4a09-b01c-7093d4192c1920
312564povidone-iodine 100 MG/ML Topical SolutionSCDc9036a83-22f5-4a09-b01c-7093d4192c1920
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYc9036a83-22f5-4a09-b01c-7093d4192c1920
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-939-0453329093904118 mL in 1 BOTTLE, PLASTIC (53329-939-04) 118 ml2017-10-270000-00-00NoNoCurrent
53329-939-0653329093906473 mL in 1 BOTTLE, PLASTIC (53329-939-06) 473 ml2007-01-010000-00-00NoNoCurrent
53329-939-0853329093908237 mL in 1 BOTTLE, PLASTIC (53329-939-08) 237 ml2007-01-010000-00-00NoNoCurrent
53329-939-135332909391359 mL in 1 BOTTLE, PLASTIC (53329-939-13) 59 ml2007-01-010000-00-00NoNoCurrent
53329-939-2353329093923946 mL in 1 BOTTLE, PLASTIC (53329-939-23) 946 ml2007-01-010000-00-00NoNoCurrent
53329-939-25533290939253785 mL in 1 BOTTLE, PLASTIC (53329-939-25) 3785 ml2007-01-010000-00-00NoNoCurrent
53329-939-4453329093944118 mL in 1 BOTTLE, PLASTIC118 mlHistorical
53329-939-695332909396988 mL in 1 BOTTLE, PLASTIC (53329-939-69) 88 ml2007-01-010000-00-00NoNoCurrent