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 112 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
application number: M003
Leader Alcohol 70 Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d2023-11-09WarningsExact identifier
application number: M003
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact 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