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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
acc349d6-2875-4814-aa6e-828fffec7f07Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de29d2-ebf1-7193-e063-6294a90ab3832026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de8eef-b344-3e25-e063-6394a90a01d82026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize Caramel LatteALCOHOLShenzhen Lantern Scicence Co.,Ltd.53df1a36-9b0a-4696-e063-6394a90a91a42026-06-09WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006e7bf-96f6-1faa-e063-6394a90ab5a32026-06-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsExact identifier
application number: M003
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
application number: M003
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
application number: M003
PESI VANILLA HYDRATIING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53325d04-26db-fc62-e063-6394a90a322a2026-06-01WarningsExact identifier
application number: M003
KOOL AID PPINK LEMONADE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53342b67-8742-1387-e063-6394a90acc742026-06-01WarningsExact identifier
application number: M003
ICEE CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53352f95-6477-25e3-e063-6394a90a9e022026-06-01WarningsExact identifier
application number: M003
JOLLY RANCHER BLUE RASPBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53357f28-a843-ec12-e063-6294a90a16fc2026-06-01WarningsExact identifier
application number: M003
SOURPATCHKIDS STRAWBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53358c4e-3021-1e85-e063-6294a90a07382026-06-01WarningsExact identifier
application number: M003
GUSHERS TROPICAL HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359191-0451-a1a0-e063-6394a90a81a12026-06-01WarningsExact identifier
application number: M003
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359746-6033-c3d2-e063-6394a90a677c2026-06-01WarningsExact identifier
application number: M003
FLUFFY STUFF COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d246-5c4c-6773-e063-6294a90a8ffa2026-06-01WarningsExact identifier
application number: M003
DUBBLE BUBBLE ORIGINAL FLAVOR BUBBLE GUM HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d97d-3d8e-fc86-e063-6394a90abaad2026-06-01WarningsExact identifier
application number: M003
MISTIFY PUMPKIN HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e262fe-9a91-59c2-e063-6394a90ac32a2026-06-01WarningsExact identifier
application number: M003
MISTIFY CINNAMON HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e23fce-8560-087e-e063-6294a90a73bb2026-06-01WarningsExact identifier
application number: M003
MISTIFY SMORES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e2c4c4-0cdb-2d24-e063-6294a90a082f2026-06-01WarningsExact identifier
application number: M003

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