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
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
Povidone Iodine Prep
Listing expiration
2026-12-31

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 13 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5599605b-28f0-a534-e063-6394a90a72132026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559987c0-7abd-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5740a2ed-e77d-3f41-e063-6394a90aec032026-07-01WarningsExact identifier
application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574ba9b9-b44d-b014-e063-6394a90af7682026-07-01WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bcf4f-ad36-5ede-e063-6294a90a0eab2026-07-01WarningsExact identifier
application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd57539bdd-641d-3c27-e063-6394a90af84a2026-07-01WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHudson Health LLC42789576-0ab4-1afb-e063-6294a90a1d272026-06-30WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5572d336-f953-90ac-e063-6394a90a2d4d2026-06-30WarningsExact identifier
application number: M003
McKesson Alcohol Prep PadISOPROPYL ALCOHOLMcKesson Medical-Surgicala8e759f3-91b1-44ae-960a-3a6cd4f746ce2026-06-30WarningsExact identifier
application number: M003
Tinted Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationf3c1c8a3-6b34-46cf-845e-c89db8f096f12026-06-30WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationa04239d8-0fa9-4c00-aa81-d7a1242bc9312026-06-30WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.555da50d-f106-f27f-e063-6294a90a61f92026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55601f99-b1a7-ffb5-e063-6394a90a37d62026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556073a0-242b-dc26-e063-6394a90a9ccf2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55709e6c-e2ec-9c16-e063-6394a90a269e2026-06-29WarningsExact identifier
application number: M003
MedPride Alcohol WipesISOPROPYL ALCOHOLShield Line LLCad2a29b2-0511-bbe4-e053-2a95a90ac0b12026-06-29WarningsExact identifier
application number: M003
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLPharma Nobis, LLCe42df0bf-cce7-3961-e053-2995a90a730a2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556f24a7-2294-424f-e063-6394a90a0b682026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread CakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556fa2a3-38de-1393-e063-6294a90add6a2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha MistETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556fcd84-0b0d-ed0b-e063-6394a90a45eb2026-06-29WarningsExact 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