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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact 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