FDA.reportPublic FDA data

sunmark Povidone-Iodine Topical

Product NDC
49348-622
11-digit product format
493480622
Labeler code
49348
Product ID
49348-622_0ce5be01-e0b9-7245-e063-6294a90acccf
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-28
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sunmark Povidone-Iodine Topical
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

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
49348-622-37sunmark Povidone-Iodine Topical237 mL in 1 BOTTLESOLUTION2379
49348-622-38sunmark Povidone-Iodine Topical473 mL in 1 BOTTLESOLUTION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-622-37ML - Milliliter49348-62262bff34c-23b1-4c58-ace5-4de9b5e144bd12012-07-24
49348-622-38ML - Milliliter49348-62204df9a48-79d9-41a5-9034-108ab993296312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
POVIDONE-IODINEACTIVE MOIETY85H0HZU99MSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-622SUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]9Current NDC, Legacy NDC, 2 package rows20231220_acc349d6-2875-4814-aa6e-828fffec7f07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNacc349d6-2875-4814-aa6e-828fffec7f079
312564povidone-iodine 100 MG/ML Topical SolutionSCDacc349d6-2875-4814-aa6e-828fffec7f079
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYacc349d6-2875-4814-aa6e-828fffec7f079

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-622-3749348062237237 mL in 1 BOTTLE (49348-622-37) 237 ml2017-12-150000-00-00NoNoCurrent
49348-622-3849348062238473 mL in 1 BOTTLE (49348-622-38) 473 ml2017-12-150000-00-00NoNoCurrent