FDA.reportPublic FDA data

POVIDONE IODINE PREP PAD Sterile

Product NDC
34645-0022
11-digit product format
346450022
Labeler code
34645
Product ID
34645-0022_085ce5e1-bafc-a353-e063-6394a90a5721
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-19
Substance
POVIDONE-IODINE
Active strength
100 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 PREP PAD Sterile
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
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
ac3aa401-a124-4eb7-9598-119be0f24dddAvailable 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
34645-0022-0POVIDONE IODINE PREP PAD Sterile1 in 1 POUCHCLOTH12
34645-0022-0POVIDONE IODINE PREP PAD Sterile0.4 mL in 1 PATCHCLOTH0.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0022POVIDONE IODINE PREP PAD STERILE (POVIDONE-IODINE) CLOTH [JIANERKANG MEDICAL CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231023_ac3aa401-a124-4eb7-9598-119be0f24ddd.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 10 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.56a3ad5f-c34a-6b90-e063-6394a90a06e92026-07-19WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56ca8257-6537-fb4e-e063-6294a90a49162026-07-17WarningsExact identifier
application number: M003
Antibacterial Hand Sanitizer Spray.ETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56caf683-bdf1-95e6-e063-6294a90a14d02026-07-17WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cbbfcf-3239-7c76-e063-6394a90a75b02026-07-17WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56cd0c67-20dd-6783-e063-6294a90ae9102026-07-17WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
application number: M003
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
application number: M003
Non -Alcohol Grape Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b5c19e-cce5-16f8-e063-6394a90a1cbd2026-07-16WarningsExact identifier
application number: M003
Non -Alcohol Cherry Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b643ec-9433-9f19-e063-6294a90a5f222026-07-16WarningsExact identifier
application number: M003
Non -Alcohol Blueberry scented Hand sanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b67ff4-5785-106e-e063-6294a90af4ec2026-07-16WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLNANTONG HAIYIWEI TEXTILE CO., LTD.56b733b1-8a15-0767-e063-6294a90af16b2026-07-16WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.56a22363-f531-d9bd-e063-6294a90a020b2026-07-15WarningsExact identifier
application number: M003
Non -Alcohol Peach Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b26868-833c-3d72-e063-6394a90aea4f2026-07-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.568f791d-d6c3-7092-e063-6294a90a4b522026-07-14WarningsExact identifier
application number: M003
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f4a507-df3f-e265-e063-6294a90acd112026-07-13WarningsExact identifier
application number: M003
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f81b63-2b08-77b1-e063-6294a90afeba2026-07-13WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC565650e6-e5f9-c010-e063-6394a90aacfa2026-07-11WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Blue DriftwoodALCOHOLScent Theory Products LLC56572ebe-d624-6389-e063-6394a90a23b42026-07-11WarningsExact identifier
application number: M003
Humco Gentian Violet 1%GENTIAN VIOLET 1%Humco Holding Group, Inc.7b4e6572-cb44-491d-8063-f7519307a8e52026-07-09WarningsExact identifier
application number: M003
Gentian Violet 1%GENTIAN VIOLET 1%Pharma Nobis, LLCe42fa7d2-47ef-0e82-e053-2995a90a67c52026-07-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNac3aa401-a124-4eb7-9598-119be0f24ddd2
797730povidone-iodine 100 MG/ML Medicated PadSCDac3aa401-a124-4eb7-9598-119be0f24ddd2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYac3aa401-a124-4eb7-9598-119be0f24ddd2
797730povidone-iodine 10 % Medicated PadSYac3aa401-a124-4eb7-9598-119be0f24ddd2
797730povidone-iodine 10 % Medicated SwabstickSYac3aa401-a124-4eb7-9598-119be0f24ddd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0022-0346450022001 PATCH in 1 POUCH (34645-0022-0) / .4 mL in 1 PATCH1 patch2022-11-190000-00-00NoNoCurrent