FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
34645-5501
11-digit product format
346455501
Labeler code
34645
Product ID
34645-5501_085c75f1-c9c9-cbb2-e063-6294a90a07c2
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-30
Substance
POVIDONE-IODINE
Active strength
7.5 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Povidone Iodine Prep
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47a504b8-b0af-030a-e054-00144ff88e88Available 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
34645-5501-0Povidone Iodine Prep25 in 1 BOXSOLUTION254
34645-5501-0Povidone Iodine Prep10 in 1 CARTONSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5501POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_47a504b8-b0af-030a-e054-00144ff88e88.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 65 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KISSES SANITIZER WHITE CHOCOLATEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff2e43-9254-e7ff-e063-6394a90a0aea2025-09-17WarningsExact identifier
application number: M003
REESES SANITIZER CHOCOLATE PEANUT BUTTERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff4496-ce10-f1c1-e063-6394a90aaff22025-09-17WarningsExact identifier
application number: M003
SWEDISH FISH SANITIZER MIX BERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff6cc3-50d8-1308-e063-6394a90a6ac22025-09-17WarningsExact identifier
application number: M003
TWIZZLERS SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff5918-e247-c171-e063-6294a90aa0f82025-09-17WarningsExact identifier
application number: M003
FLUFFY STUFF SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff7fd6-5e3d-f38b-e063-6294a90afc022025-09-17WarningsExact identifier
application number: M003
MISTIFY SANITIZER CARAMEL PISTACHIOALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3effa71e-bbf1-36de-e063-6294a90ab9e32025-09-17WarningsExact identifier
application number: M003
STRAWBERRY SHORTCAKE SANITIZER STRAWBERRY ICINGALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f033c93-1438-8b8d-e063-6394a90a93b52025-09-17WarningsExact identifier
application number: M003
Sherk sanitizer waffle syrupALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f0357e9-35c2-f983-e063-6294a90a5dac2025-09-17WarningsExact identifier
application number: M003
STRAWBERRY SHORTCAKE SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f032275-4c3f-6d78-e063-6394a90a038d2025-09-17WarningsExact identifier
application number: M003
SHERK SANITIZER GREEN APPLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f03af0d-b1a6-8fd1-e063-6294a90ad0912025-09-17WarningsExact identifier
application number: M003
SHERK SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f03d420-e41f-a923-e063-6294a90ab6d32025-09-17WarningsExact identifier
application number: M003
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
application number: M003
Booboo BubblesHYDROGEN PEROXIDE72 Seasons LLC3e8b538c-d4d6-7d76-e063-6394a90a96d12025-09-15WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece368e-1c98-6275-e063-6294a90a1dec2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece74d3-fec4-55cc-e063-6394a90afda92025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece4de7-4c1c-5dde-e063-6294a90ae56e2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf17c6-3a97-7dc5-e063-6294a90a85c62025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf0c05-15f2-cf9e-e063-6294a90ab8462025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cherry BerryETHYL ALCOHOL 70%MY IMPORTS USA LLC3eced383-2f0b-3c0d-e063-6394a90afce42025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf2280-56e6-4770-e063-6394a90a3e3c2025-09-14WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037204povidone-iodine 7.5 % Medicated PadPSN47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 75 MG/ML Medicated PadSCD47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY47a504b8-b0af-030a-e054-00144ff88e884
1037204povidone-iodine 7.5 % Medicated PadSY47a504b8-b0af-030a-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5501-03464555010010 BOX in 1 CARTON (34645-5501-0) / 25 PATCH in 1 BOX / .045 g in 1 PATCH10 box2017-02-030000-00-00NoNoCurrent