FDA.reportPublic FDA data

Povidone Iodine Prep Pad

Product NDC
34645-5500
11-digit product format
346455500
Labeler code
34645
Product ID
34645-5500_085bd3da-9cdd-fe96-e063-6294a90ab572
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-30
Substance
POVIDONE-IODINE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage34645-550034645-5500-0DDiscontinued by firm2026-10-23

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 g/100g

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
47a504b8-b0c0-030a-e054-00144ff88e88Available 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
34645-5500-0Povidone Iodine Prep Pad1 in 1 CARTONSOLUTION15
34645-5500-0Povidone Iodine Prep Pad100 in 1 BOXSOLUTION1005
34645-5500-1Povidone Iodine Prep Pad100 in 1 BOXSOLUTION1005
34645-5500-1Povidone Iodine Prep Pad1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5500POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]5Current NDC, Legacy NDC, 4 package rows20231023_47a504b8-b0c0-030a-e054-00144ff88e88.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 90 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN47a504b8-b0c0-030a-e054-00144ff88e885
797730povidone-iodine 100 MG/ML Medicated PadSCD47a504b8-b0c0-030a-e054-00144ff88e885
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY47a504b8-b0c0-030a-e054-00144ff88e885
797730povidone-iodine 10 % Medicated PadSY47a504b8-b0c0-030a-e054-00144ff88e885
797730povidone-iodine 10 % Medicated SwabstickSY47a504b8-b0c0-030a-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5500-0346455500001 in 1 CARTONHistorical
34645-5500-1346455500011 BOX in 1 CARTON (34645-5500-1) / 100 PATCH in 1 BOX / .043 g in 1 PATCH1 box2017-01-300000-00-00NoNoCurrent