FDA.reportPublic FDA data

Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)

Product NDC
84128-009
11-digit product format
841280009
Labeler code
84128
Product ID
84128-009_529b8aca-4b37-a642-e063-6394a90a2cb0
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone-Iodine, Isopropyl Alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
XINXIANG XINDA TECHNOLOGY CO.,LTD
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-13
Substance
ISOPROPYL ALCOHOL; POVIDONE-IODINE
Active strength
725; 83 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL725 mg/mL
POVIDONE-IODINE83 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302, 85H0HZU99M

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
84128-009-03Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-03Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)20 in 1 BOXSWAB201
84128-009-06Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-06Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)20 in 1 BOXSWAB201
84128-009-10Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)10 in 1 BOXSWAB101
84128-009-10Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-26Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-26Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)10 in 1 BOXSWAB101
84128-009-30Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-30Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)10 in 1 BOXSWAB101
84128-009-35Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)1 in 1 BAGSWAB11
84128-009-35Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)10 in 1 BOXSWAB101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84128-009-038412800090320 BAG in 1 BOX (84128-009-03) / 1 APPLICATOR in 1 BAG / 3 mL in 1 APPLICATOR20 bag2026-05-13NoNoHistorical
84128-009-068412800090620 BAG in 1 BOX (84128-009-06) / 1 APPLICATOR in 1 BAG / 6 mL in 1 APPLICATOR20 bag2026-05-13NoNoHistorical
84128-009-108412800091010 BAG in 1 BOX (84128-009-10) / 1 APPLICATOR in 1 BAG / 10.5 mL in 1 APPLICATOR10 bag2026-05-13NoNoHistorical
84128-009-268412800092610 BAG in 1 BOX (84128-009-26) / 1 APPLICATOR in 1 BAG / 26 mL in 1 APPLICATOR10 bag2026-05-13NoNoHistorical
84128-009-308412800093010 BAG in 1 BOX (84128-009-30) / 1 APPLICATOR in 1 BAG / 30 mL in 1 APPLICATOR10 bag2026-05-13NoNoHistorical
84128-009-358412800093510 BAG in 1 BOX (84128-009-35) / 1 APPLICATOR in 1 BAG / 35 mL in 1 APPLICATOR10 bag2026-05-13NoNoHistorical