FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
60913-051
11-digit product format
609130051
Labeler code
60913
Product ID
60913-051_41d30914-6c97-01ea-e063-6394a90a9f03
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
PHOENIX HEALTHCARE SOLUTIONS, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-23
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
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 Prep
Brand name suffix
Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a0aba34-3f96-46b6-8521-f4388fb73edfAvailable 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
60913-051-01Povidone Iodine PrepSwabstick50 in 1 BOXSOLUTION5010
60913-051-01Povidone Iodine PrepSwabstick1 in 1 POUCHSOLUTION110
60913-051-03Povidone Iodine PrepSwabstick25 in 1 BOXSOLUTION2510
60913-051-03Povidone Iodine PrepSwabstick3 in 1 POUCHSOLUTION310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60913-051POVIDONE IODINE PREP SWABSTICK (POVIDONE IODINE) SOLUTION [PHOENIX HEALTHCARE SOLUTIONS, LLC]9Current NDC, Legacy NDC, 4 package rows20241019_8a0aba34-3f96-46b6-8521-f4388fb73edf.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 104 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 100 MG/ML Medicated PadSCD8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % Medicated PadSY8a0aba34-3f96-46b6-8521-f4388fb73edf10
797730povidone-iodine 10 % Medicated SwabstickSY8a0aba34-3f96-46b6-8521-f4388fb73edf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60913-051-016091300510150 POUCH in 1 BOX (60913-051-01) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR50 pouch2015-06-230000-00-00NoNoCurrent
60913-051-036091300510325 POUCH in 1 BOX (60913-051-03) / 3 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR25 pouch2015-06-230000-00-00NoNoCurrent