FDA.reportPublic FDA data

Povidone Iodine

Product NDC
68786-140
11-digit product format
687860140
Labeler code
68786
Product ID
68786-140_47e7d21f-e345-6413-e063-6294a90aa9be
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-17
Substance
POVIDONE-IODINE
Active strength
.1 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct68786-140IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68786-14068786-140-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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-IODINE.1 g/1

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
3ef9a05b-e434-4f6d-94a1-94aa6723fe8fAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-11-18Povidone Iodine Prep Pad
2020-11-18Povidone Iodine Prep Pad
2020-01-31Povidone Iodine Prep Pad
2020-01-31Povidone Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-140-01Povidone Iodine10 in 1 CASESWAB106
68786-140-01Povidone Iodine100 in 1 BOXSWAB1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TPOVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-140POVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]5Current NDC, Legacy NDC, 2 package rows20240125_3ef9a05b-e434-4f6d-94a1-94aa6723fe8f.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 15 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
application number: M003
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGETarget Corporation326daa64-165a-cea6-e063-6294a90afbab2026-06-22WarningsExact identifier
application number: M003
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cea78b-515c-9562-e063-6394a90af1b42026-06-21WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cecbb4-5d85-dacf-e063-6294a90af8072026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cef14d-dd2b-905f-e063-6294a90a66ba2026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cf590a-2a74-d8fe-e063-6294a90a64382026-06-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
application number: M003
PVP Scrub SolutionPOVIDONE IODINEMcKesson Medical-Surgical Inc.49db333e-36e1-1965-e054-00144ff8d46c2026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN3ef9a05b-e434-4f6d-94a1-94aa6723fe8f6
797730povidone-iodine 100 MG/ML Medicated PadSCD3ef9a05b-e434-4f6d-94a1-94aa6723fe8f6
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY3ef9a05b-e434-4f6d-94a1-94aa6723fe8f6
797730povidone-iodine 10 % Medicated PadSY3ef9a05b-e434-4f6d-94a1-94aa6723fe8f6
797730povidone-iodine 10 % Medicated SwabstickSY3ef9a05b-e434-4f6d-94a1-94aa6723fe8f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-140-016878601400110 BOX in 1 CASE (68786-140-01) / 100 PACKET in 1 BOX / 1 SWAB in 1 PACKET10 box2013-04-170000-00-00NoNoCurrent