FDA.reportPublic FDA data

povidone iodine

Product NDC
0904-1103
11-digit product format
009041103
Labeler code
0904
Product ID
0904-1103_31d1e593-4c71-352b-e063-6294a90a1310
Type
HUMAN OTC DRUG
Nonproprietary name
povidone iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-21
Substance
POVIDONE-IODINE
Active strength
100 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-1103-09povidone iodine237 mL in 1 BOTTLESOLUTION23710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-1103-09ML - Milliliter0904-1103ec538c10-93a8-4fae-8141-9c8e2674218812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
IodineACTIVE MOIETY9679TC07X4POVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37POVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-1103POVIDONE IODINE SOLUTION [MAJOR PHARMACEUTICALS]10Current NDC, Legacy NDC, 1 package rows20250406_1e5aed0c-bd51-4ac8-9877-71bf18050dfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN1e5aed0c-bd51-4ac8-9877-71bf18050dfd10
312564povidone-iodine 100 MG/ML Topical SolutionSCD1e5aed0c-bd51-4ac8-9877-71bf18050dfd10
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1e5aed0c-bd51-4ac8-9877-71bf18050dfd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-1103-0900904110309237 mL in 1 BOTTLE (0904-1103-09) 237 ml2011-12-210000-00-00NoNoCurrent