FDA.reportPublic FDA data

Povidone Iodine

Product NDC
69396-112
11-digit product format
693960112
Labeler code
69396
Product ID
69396-112_29b3ae6b-a09b-f62c-e063-6294a90a150b
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-23
Substance
POVIDONE-IODINE
Active strength
100 mg/g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

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
312563Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f80ccd8a-9b9b-bbf9-e053-6394a90ac827Available 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
69396-112-20Povidone Iodine1 in 1 BOXOINTMENT12
69396-112-20Povidone Iodine28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-112POVIDONE IODINE (POVIDONE IODINE 10%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20241222_f80ccd8a-9b9b-bbf9-e053-6394a90ac827.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 63 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)1a3a789d-8c51-4661-84fe-df80ed70e6f12025-10-03WarningsExact identifier
application number: M003
Equate Antibacterial Fresh Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2bc26d8-3e46-e479-e053-2995a90abc0a2025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Wipes FreshBENZALKONIUM CHLORIDEWalmart, Inc.21d86d5b-46ee-6ffd-e063-6394a90ab0e52025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Wipes CitrusBENZALKONIUM CHLORIDEWalmart, Inc.2450dc1b-0c89-c92a-e063-6394a90afe222025-10-01WarningsExact identifier
application number: M003
Equate Antibacterial Citrus Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2cb4c64-66fc-58e4-e053-2a95a90a7f662025-10-01WarningsExact identifier
application number: M003
Kroger Antibacterial Hand WipesBENZALKONIUM CHLORIDEThe Kroger Co.17e29138-8c1f-e3b1-e063-6294a90a5d482025-10-01WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)2f1c3e24-ea71-4634-9ec1-670349b43a502025-10-01WarningsExact identifier
application number: M003
Fresh Feels Hand Sanitizer MistFRESH FEELS HAND SANITIZER MISTZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3ffda86b-6b1d-8f0d-e063-6394a90aafaf2025-09-30WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ee484505-3bb1-2989-e053-2995a90aea2b2025-09-30WarningsExact identifier
application number: M003
Xpect First Aid CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLCintas Corporationf7112e5d-c8c4-42ad-8a65-24bfc32d4aea2025-09-30WarningsExact identifier
application number: M003
Xpect Antiseptic WipesANTISEPTIC CLEANSERCintas Corporation8f1fd933-965e-42ec-ab96-47cfe780f9632025-09-29WarningsExact identifier
application number: M003
EVR Alcohol Prep PadsISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffba233-6106-f633-e063-6394a90a96fe2025-09-29WarningsExact identifier
application number: M003
ProHeal Alcohol Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffc0619-eb13-77af-e063-6394a90a2fd92025-09-29WarningsExact identifier
application number: M003
ProHeal BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.3ffc3f34-086d-1d18-e063-6294a90a71bb2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Alcohol WipeISOPROPYL ALCOHOLCintas Corporation6a71449e-9a97-4923-8ec1-b1deb45b57462025-09-29WarningsExact identifier
application number: M003
Northside Hospital Mothers Kit, Grey BackpackALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc0868060e-d593-4cb2-b3d2-6c59d1ae5efc2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Antiseptic WipeBENZALKONIUM CHLORIDECintas Corporationa23f3685-7213-4cc0-97b2-588fb12247922025-09-29WarningsExact identifier
application number: M003
Xpect Alcohol WipesALCOHOL WIPESCintas Corporation51185b9a-ed6b-4a49-b524-b3ff0d5c62902025-09-29WarningsExact identifier
application number: M003
Super-Stop BloodClotterBLOOD CLOTTERCintas Corpd910ee9b-187d-49a9-ab96-281730db25752025-09-26WarningsExact identifier
application number: M003
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEAocai Biotechnology Huizhou Co Ltd3fa738ce-0a04-fa11-e063-6294a90aba882025-09-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312563povidone-iodine 10 % Topical OintmentPSNf80ccd8a-9b9b-bbf9-e053-6394a90ac8272
312563povidone-iodine 0.1 MG/MG Topical OintmentSCDf80ccd8a-9b9b-bbf9-e053-6394a90ac8272
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSYf80ccd8a-9b9b-bbf9-e053-6394a90ac8272
312563povidone-iodine 10 % Topical OintmentSYf80ccd8a-9b9b-bbf9-e053-6394a90ac8272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-112-20693960112201 TUBE in 1 BOX (69396-112-20) / 28.3 g in 1 TUBE1 tube2022-12-23NoNoCurrent