FDA.reportPublic FDA data

Povidone Iodine

Product NDC
0395-9129
11-digit product format
003959129
Labeler code
0395
Product ID
0395-9129_0c9368f8-3986-07dd-e063-6394a90ac66a
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine Spray 5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-23
Substance
POVIDONE-IODINE
Active strength
50 mg/mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE50 mg/mL

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
238850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7bb80c4-bbc0-21ea-e053-2995a90a52c1Available 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
0395-9129-93Povidone Iodine89 mL in 1 CONTAINERLIQUID894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9129POVIDONE IODINE (POVIDONE-IODINE SPRAY 5%) LIQUID [HUMCO HOLDING GROUP, INC.]4Current NDC, Legacy NDC, 1 package rows20231216_a7bb80c4-bbc0-21ea-e053-2995a90a52c1.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 78 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Band Aid Antiseptic Cleansing LiquidBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEKenvue Brands LLCd2a6e0d2-5b9b-11c0-e053-2a95a90a4df02025-05-26WarningsExact identifier
application number: M003
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
application number: M003
BIOPURE20CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.359f43c7-682a-ba1c-e063-6394a90a8dcb2025-05-21WarningsExact identifier
application number: M003
Walgreens Advanced Wound WashBENZALKONIUM CHLORIDEWalgreens Co.25c6d81c-d462-5a89-e063-6294a90a08f32025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Cozy ComfortALCOHOLScent Theory Products LLC35965496-d101-c604-e063-6294a90a1a482025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Whipped ChaiALCOHOLScent Theory Products LLC35966f42-1f59-e5f5-e063-6294a90a99822025-05-20WarningsExact identifier
application number: M003
VLITEPRO BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.3543d2f6-16d3-aa65-e063-6294a90a96372025-05-19WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.db649f36-04b9-47f3-a334-94d3247f80de2025-05-16WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer With AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.52dccfd7-c288-469e-a067-ee6e5776fd6b2025-05-16WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.49a3c389-33e3-4bd7-a3e7-fe5f4f722bdf2025-05-16WarningsExact identifier
application number: M003
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ebff92-c075-efdb-e063-6394a90a768f2025-05-12WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
application number: M003
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
application number: M003
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
application number: M003
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238850povidone-iodine 5 % Topical SprayPSNa7bb80c4-bbc0-21ea-e053-2995a90a52c14
238850povidone-iodine 50 MG/ML Topical SpraySCDa7bb80c4-bbc0-21ea-e053-2995a90a52c14
238850povidone-iodine 5 % Topical SpraySYa7bb80c4-bbc0-21ea-e053-2995a90a52c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-9129-930039591299389 mL in 1 CONTAINER (0395-9129-93) 89 ml2020-01-230000-00-00NoNoCurrent