FDA.reportPublic FDA data

Povidone Iodine Gel Swabstick

Product NDC
68786-418
11-digit product format
687860418
Labeler code
68786
Product ID
68786-418_47e7d3e3-b5aa-6b71-e063-6294a90a5633
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine Gel Swabstick
Dosage form
GEL
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
POVIDONE-IODINE
Active strength
10 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 Gel Swabstick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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
312562Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1058b4ff-c337-7a5a-e063-6394a90aca41Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-418-01Povidone Iodine Gel Swabstick50 in 1 BOXGEL502
68786-418-01Povidone Iodine Gel Swabstick0.3 mL in 1 PACKETGEL0.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-418POVIDONE IODINE GEL SWABSTICK GEL [SION BIOTEXT MEDICAL LTD]1Current NDC, 2 package rows20240202_1058b4ff-c337-7a5a-e063-6394a90aca41.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 27 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
application number: M003
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
application number: M003
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLMY IMPORTS USA LLC4dbe636b-f376-7e30-e063-6394a90a722b2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLMY IMPORTS USA LLC4dbe7020-e302-8706-e063-6394a90abe7c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLMY IMPORTS USA LLC4dbe79d2-ee73-a8ed-e063-6394a90a7db52026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLMY IMPORTS USA LLC4dbe8d3f-afac-cc82-e063-6294a90ae3092026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312562povidone-iodine 10 % Topical GelPSN1058b4ff-c337-7a5a-e063-6394a90aca412
312562povidone-iodine 0.1 MG/MG Topical GelSCD1058b4ff-c337-7a5a-e063-6394a90aca412
312562povidone-iodine 10 % (titratable iodine 1 % ) Topical GelSY1058b4ff-c337-7a5a-e063-6394a90aca412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68786-418-016878604180150 PACKET in 1 BOX (68786-418-01) / .3 mL in 1 PACKET50 packet2024-02-01NoNoCurrent