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 72 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafetec of America, Inc.89310a64-c4cc-46c6-8294-c4d28cd881182025-08-08WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDELJ Pharmae468ad76-b26a-49f0-a2c5-a027299babc72025-08-05WarningsExact identifier
application number: M003
Armor Antibacterial Body Treatment Benzalkonium ChlorideBENZALKONIUM CHLORIDERida LLC95761213-bf90-4ba6-a17b-7470a0f316232025-08-05WarningsExact identifier
application number: M003
AerowipeANSTISEPTIC WIPEAero Healthcare34ca12c7-9281-263c-e054-00144ff8d46c2025-08-01WarningsExact identifier
application number: M003
KeriCleanz ANTISEPTICHYDROGEN PEROXIDEKericure Inc.79b0d9bb-0fa5-4e45-ab74-9ff0e12152382025-07-31WarningsExact identifier
application number: M003
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
application number: M003
WICKED HAND SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e9352-15c9-954a-e063-6294a90a7a672025-07-29WarningsExact identifier
application number: M003
WICKED HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e7e57-6472-6cca-e063-6294a90a63a62025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER COCONUTALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0f1b10-ed25-0949-e063-6394a90a6a802025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER MANGOALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0fd685-c807-75e4-e063-6394a90a3d652025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER PEACHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b104177-be18-8b50-e063-6394a90a3b392025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b4680c7-562f-c78b-e063-6294a90a5d1a2025-07-29WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes EucalyptusALCOHOL SOLUTIONNoshinku3affe837-6789-6213-e063-6294a90a9fea2025-07-28WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes LavendulaALCOHOL SOLUTIONNoshinku3b0016b4-ccad-5eb5-e063-6294a90a36ca2025-07-28WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes BergamotALCOHOL SOLUTIONNoshinku3b0035e8-d95e-f5f2-e063-6394a90aca012025-07-28WarningsExact identifier
application number: M003
Kills Hand SanitizerALCOHOLDermazone LLCced12de7-32c1-4882-af22-f5373b2ceddb2025-07-25WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact 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