FDA.reportPublic FDA data

Povidone-Iodine

Product NDC
0904-7639
11-digit product format
009047639
Labeler code
0904
Product ID
0904-7639_59041cb4-9e59-5d10-e063-6394a90a6b07
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-14
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
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
59041ca3-a195-5a20-e063-6394a90a2ac9Available on FDA.report

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 98 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003
Instant Hand SanitizerHAND SANITIZERRaining Rose, Inc.2656d129-df88-4489-e063-6394a90a4b492024-11-07WarningsExact identifier
application number: M003
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.0742f251-5fc9-c015-e063-6394a90a79b12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomETHYL ALCOHOLWhole Foods Market, Inc.07436407-7a15-7cee-e063-6294a90a96512024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.07f7e966-e57e-dede-e063-6294a90acbf52024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.ec8c7597-a3f1-65a8-e053-2995a90a69a12024-11-02WarningsExact identifier
application number: M003
Lemongrass Hand SanitizerALCOHOLNatural Essentials, Inc.25ca3908-24aa-5e4f-e063-6394a90a7a882024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Decolorized IodineETHYL ALCOHOLSanvall Enterprises, Inc16c92427-84d2-cad5-e063-6394a90af4352024-10-31WarningsExact identifier
application number: M003
Sanar Naturals MercurochromeBENZALKONIUM CHLOLRIDESanvall Enterprises, Inc16c6c2f0-0f08-e640-e063-6394a90aa01d2024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Gentian VioletGENTIAN VIOLETSanvall Enterprises, Inc1922518d-e49b-5010-e063-6394a90a91122024-10-31WarningsExact identifier
application number: M003
Lavender Hand SanitizerALCOHOLNatural Essentials, Inc.25cada8c-8c80-c140-e063-6294a90a33362024-10-31WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7639-5400904763954237 mL in 1 BOTTLE, PLASTIC (0904-7639-54) 237 ml2026-08-14NoNoCurrent