FDA.reportPublic FDA data

Povidone Iodine Prep Pad

Product NDC
34645-4008
11-digit product format
346454008
Labeler code
34645
Product ID
34645-4008_085b28a4-8db7-0685-e063-6294a90a0d08
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-01
Substance
POVIDONE-IODINE
Active strength
10 mg/100mL
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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct34645-4008EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage34645-400834645-4008-3EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 mg/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
be85ec5b-eb49-4f1a-a87d-5c9705a20f23Available 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
34645-4008-3Povidone Iodine Prep Pad0.4 mL in 1 POUCHSWAB0.46

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]2
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4008POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANERKANG MEDICAL CO., LTD]6Current NDC, Legacy NDC, 1 package rows20231023_be85ec5b-eb49-4f1a-a87d-5c9705a20f23.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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
Micotrin ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
application number: M005
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsExact identifier
application number: M005
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
application number: M005
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
application number: M005
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
application number: M005
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
application number: M005
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M005
Mentholatum Heel Revival CreamMENTHOLATUM HEEL REVIVAL CREAMThe Mentholatum Company21b643c2-eb6e-8939-e063-6394a90aaeac2024-09-09WarningsExact identifier
application number: M005
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Tropical Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.3645359c-06a2-4b97-b982-c54e4a0b8cda2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Coastal Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.645c09dc-15a4-481f-a605-f12fb8f8e9bd2024-09-04WarningsExact identifier
application number: M005
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
application number: M005
ANTIFUNGAL FOOTTOLNAFTATEUniversal Distribution Center LLC10579848-5793-4d72-ad5f-62d191c710742024-07-16WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNbe85ec5b-eb49-4f1a-a87d-5c9705a20f236
797730povidone-iodine 100 MG/ML Medicated PadSCDbe85ec5b-eb49-4f1a-a87d-5c9705a20f236
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYbe85ec5b-eb49-4f1a-a87d-5c9705a20f236
797730povidone-iodine 10 % Medicated PadSYbe85ec5b-eb49-4f1a-a87d-5c9705a20f236
797730povidone-iodine 10 % Medicated SwabstickSYbe85ec5b-eb49-4f1a-a87d-5c9705a20f236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
34645-4008-334645400803.4 mL in 1 POUCH (34645-4008-3) 2010-01-010000-00-00NoNoCurrent