FDA.reportPublic FDA data

Antiseptic Povidone Iodine Prep Pad

Product NDC
84219-006
11-digit product format
842190006
Labeler code
84219
Product ID
84219-006_1507ac3e-81e3-892c-e063-6394a90ac565
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
CLOTH
Route
TOPICAL
Labeler
M-star (Hubei) Health&Care Products Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
POVIDONE-IODINE
Active strength
100 mg/g
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
Antiseptic Povidone Iodine Prep Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 mg/g

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
fc76c1f3-b48e-4276-890d-5b8e5a894e62Available 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
84219-006-00Antiseptic Povidone Iodine Prep Pad0.45 g in 1 PATCHCLOTH0.451
84219-006-00Antiseptic Povidone Iodine Prep Pad1 in 1 POUCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-006ANTISEPTIC POVIDONE IODINE PREP PAD (POVIDONE-IODINE) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 2 package rows20240515_fc76c1f3-b48e-4276-890d-5b8e5a894e62.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 37 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact identifier
application number: M003
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 91%ISOPROPYL ALCOHOLLJ Pharma07cba887-a568-4b92-91ab-2e7831f24ab52026-01-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERite Aid Corporation2f8abb6f-460f-47bf-811d-734126aa3f0b2026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Drs. pharmacy triple antibiotic plus lidocaineBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENTOL PHARMA TECH, LLC49a73b0f-90d9-3a4b-e063-6294a90acfb02026-01-30WarningsExact identifier
application number: M003
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDEWal-Mart Stores, Inc.f3911d79-3169-71c3-e053-2a95a90ae8432026-01-29WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEAmerifoods Trading Co38b15693-7e5f-4c85-915e-9937ea018a832026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticFIRST AID ANTISEPTICAmerisource Bergen6719db46-a6e3-4f0a-828c-fe89a51879892026-01-29Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSNfc76c1f3-b48e-4276-890d-5b8e5a894e621
797730povidone-iodine 100 MG/ML Medicated PadSCDfc76c1f3-b48e-4276-890d-5b8e5a894e621
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYfc76c1f3-b48e-4276-890d-5b8e5a894e621
797730povidone-iodine 10 % Medicated PadSYfc76c1f3-b48e-4276-890d-5b8e5a894e621
797730povidone-iodine 10 % Medicated SwabstickSYfc76c1f3-b48e-4276-890d-5b8e5a894e621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84219-006-00842190006001 PATCH in 1 POUCH (84219-006-00) / .45 g in 1 PATCH1 patch2024-05-15NoNoCurrent