FDA.reportPublic FDA data

Premier Value Povidone Iodine

Product NDC
68016-415
11-digit product format
680160415
Labeler code
68016
Product ID
68016-415_0cf4f274-9fc2-f48e-e063-6394a90a9d3f
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chain Drug Consortium
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
POVIDONE-IODINE
Active strength
100 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
Premier Value Povidone Iodine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
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
5cc9d782-5f7e-27d9-e053-2991aa0a2428Available 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
68016-415-00Premier Value Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-415-00ML - Milliliter68016-4153ee2aa7b-5ddd-4a6d-9c57-77f1f861165d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-415PREMIER VALUE POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [CHAIN DRUG CONSORTIUM]5Current NDC, Legacy NDC, 1 package rows20231221_5cc9d782-5f7e-27d9-e053-2991aa0a2428.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 102 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - StrawberryALCOHOLGanzhou Olivee Cosmetic Co., Ltd.7c4bab88-af65-48c2-8440-3ba7b139c0132024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - AppleALCOHOLGanzhou Olivee Cosmetic Co., Ltd.362d3233-79ac-41d8-9991-b5fc75c6cae92024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - PeachALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ad28fe19-2b81-40c2-8ffb-f9b09c79def82024-09-10WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
application number: M003
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30fc7f33-238c-42a3-93a1-72b98d303d9a2024-08-28WarningsExact identifier
application number: M003
MANGO SORBET SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.d44e43e1-717d-47a1-a152-45f12288cbd22024-08-28WarningsExact identifier
application number: M003
COCONUT VANILLA SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.574324ee-d98b-4939-889c-21ed04a4e46d2024-08-28WarningsExact identifier
application number: M003
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.997d0ff0-96b4-4b91-87fc-8f67d9b5013c2024-08-28WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202dfeac-6e69-8667-e063-6294a90a26d22024-08-21WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsExact identifier
application number: M003
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
application number: M003
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
application number: M003
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
application number: M003
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
application number: M003
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
application number: M003
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
application number: M003
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN5cc9d782-5f7e-27d9-e053-2991aa0a24285
312564povidone-iodine 100 MG/ML Topical SolutionSCD5cc9d782-5f7e-27d9-e053-2991aa0a24285
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY5cc9d782-5f7e-27d9-e053-2991aa0a24285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-415-0068016041500237 mL in 1 BOTTLE, PLASTIC (68016-415-00) 237 ml2017-10-300000-00-00NoNoCurrent