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
2026-12-31

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 25 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer 3pk with Leather CaseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f036ba3-3f21-d04b-e063-6294a90ad7d72026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eeedd3e-d4b4-9967-e063-6394a90abf332026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eef33c2-695a-3a32-e063-6394a90a0a7b2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PinkALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eefc5bc-7dd4-e4c8-e063-6394a90a9a512026-04-08WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
application number: M003
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLAmazon.com Services LLC5369424a-ccbd-4dc6-af6b-7876484a9fe62026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
application number: M003
Povidone Iodine 10%POVIDONE IODINEFarmacias De Similares TX LLC4e6baed0-ea31-79e2-e063-6294a90a3bb12026-04-01WarningsExact identifier
application number: M003
FRESH LINES SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5005d615-d9c3-a46d-e063-6394a90af88a2026-04-01WarningsExact 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