FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
34645-5504
11-digit product format
346455504
Labeler code
34645
Product ID
34645-5504_085caf56-2a08-923c-e063-6294a90af7f7
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
10 g/100g
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 Prep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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 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
47a5726f-d314-50d9-e054-00144ff8d46cAvailable 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
34645-5504-0Povidone Iodine Prep25 in 1 BOXSOLUTION254
34645-5504-0Povidone Iodine Prep10 in 1 CARTONSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5504POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_47a5726f-d314-50d9-e054-00144ff8d46c.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 1 of 115 · 2,294 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact identifier
application number: M003
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd4b642dfa-f044-4410-81e4-142f0497f0f32026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
application number: M003
Wish Sanitizing Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.c81c0924-bb01-4fa2-b933-8777358e45e72026-08-05WarningsExact identifier
application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
application number: M003
Medi-First Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd31fe110-6d75-bf15-e053-2a95a90a86942026-08-03WarningsExact identifier
application number: M003
First ShieldHYDROGEN PEROXIDEEVER READY FIRST AID94307d2f-5366-4fdb-b919-4a8658dda0582026-08-03WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN47a5726f-d314-50d9-e054-00144ff8d46c4
312564povidone-iodine 100 MG/ML Topical SolutionSCD47a5726f-d314-50d9-e054-00144ff8d46c4
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY47a5726f-d314-50d9-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5504-03464555040010 BOX in 1 CARTON (34645-5504-0) / 25 PATCH in 1 BOX / .045 g in 1 PATCH10 box2017-02-030000-00-00NoNoCurrent