FDA.reportPublic FDA data

Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)

Product NDC
84128-007
11-digit product format
841280007
Labeler code
84128
Product ID
84128-007_51c2937c-154e-0840-e063-6394a90a0899
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine
Dosage form
SWAB
Route
TOPICAL
Labeler
XINXIANG XINDA TECHNOLOGY CO.,LTD
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-13
Substance
POVIDONE-IODINE
Active strength
75 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
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE75 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
1037204Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
51c29301-978a-0d46-e063-6394a90ab9e4Available 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
84128-007-03Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-03Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)20 in 1 BOXSWAB201
84128-007-06Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-06Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)20 in 1 BOXSWAB201
84128-007-10Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)10 in 1 BOXSWAB101
84128-007-10Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-26Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)10 in 1 BOXSWAB101
84128-007-26Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-30Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)10 in 1 BOXSWAB101
84128-007-30Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-35Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)1 in 1 BAGSWAB11
84128-007-35Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)10 in 1 BOXSWAB101

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 58 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPhoenix Healthcare Solutions LLCc68d2d73-be78-8e1c-e053-2995a90a3a372025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCca9f8e68-cc15-42b4-81fd-e114e6a6d7df2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
application number: M003
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037204povidone-iodine 7.5 % Medicated PadPSN51c29301-978a-0d46-e063-6394a90ab9e41
1037204povidone-iodine 75 MG/ML Medicated PadSCD51c29301-978a-0d46-e063-6394a90ab9e41
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY51c29301-978a-0d46-e063-6394a90ab9e41
1037204povidone-iodine 7.5 % Medicated PadSY51c29301-978a-0d46-e063-6394a90ab9e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84128-007-038412800070320 BAG in 1 BOX (84128-007-03) / 1 APPLICATOR in 1 BAG / 3 mL in 1 APPLICATOR20 bag2026-05-13NoNoCurrent
84128-007-068412800070620 BAG in 1 BOX (84128-007-06) / 1 APPLICATOR in 1 BAG / 6 mL in 1 APPLICATOR20 bag2026-05-13NoNoCurrent
84128-007-108412800071010 BAG in 1 BOX (84128-007-10) / 1 APPLICATOR in 1 BAG / 10.5 mL in 1 APPLICATOR10 bag2026-05-13NoNoCurrent
84128-007-268412800072610 BAG in 1 BOX (84128-007-26) / 1 APPLICATOR in 1 BAG / 26 mL in 1 APPLICATOR10 bag2026-05-13NoNoCurrent
84128-007-308412800073010 BAG in 1 BOX (84128-007-30) / 1 APPLICATOR in 1 BAG / 30 mL in 1 APPLICATOR10 bag2026-05-13NoNoCurrent
84128-007-358412800073510 BAG in 1 BOX (84128-007-35) / 1 APPLICATOR in 1 BAG / 35 mL in 1 APPLICATOR10 bag2026-05-13NoNoCurrent