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
2026-12-31
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Povidone Iodine Prep Pad
Listing expiration
2026-12-31

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 1 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Radthary GROIN ANTIFUNGAL CreamMICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1945f3-84ba-f3dc-e063-6294a90ab8a02026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
HSENJT Antifungal CreamMICONAZOLE NITRATEHuizhou Haosen Trading Co., Ltd.5aa587f5-5ddf-542a-e063-6294a90a522b2026-09-07WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
AOUGK SALICYLIC ACID WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5ac88b51-b46c-5cc6-e063-6394a90af9e52026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact 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