FDA.reportPublic FDA data

Profend Nasal Antiseptic Kit

Product NDC
10819-3889
11-digit product format
108193889
Labeler code
10819
Product ID
10819-3889_4d4d5003-bf7f-046e-e063-6394a90a3fc6
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine USP, 10% w/w
Dosage form
SWAB
Route
TOPICAL
Labeler
Professional Disposables International, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-17
Substance
POVIDONE-IODINE
Active strength
10 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
Profend Nasal Antiseptic Kit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 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
1037205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3eeddd1d-7190-b35c-e063-6394a90ae816Available 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
10819-3889-1Profend Nasal Antiseptic Kit0.75 mL in 1 TUBE, WITH APPLICATORSWAB0.752
10819-3889-2Profend Nasal Antiseptic Kit4 in 1 BOXSWAB42
10819-3889-3Profend Nasal Antiseptic Kit12 in 1 CARTONSWAB122

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Profend Nasal Antiseptic KitPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.3eeddd1d-7190-b35c-e063-6394a90ae8162026-03-18WarningsExact identifier
ndc (product): 10819-3889

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037205povidone-iodine 1 % Medicated PadPSN3eeddd1d-7190-b35c-e063-6394a90ae8162
1037205povidone-iodine 10 MG/ML Medicated PadSCD3eeddd1d-7190-b35c-e063-6394a90ae8162
1037205povidone-iodine 1 % Medicated PadSY3eeddd1d-7190-b35c-e063-6394a90ae8162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10819-3889-1108193889010.75 mL in 1 TUBE, WITH APPLICATOR0.75 mlHistorical
10819-3889-2108193889024 in 1 BOXHistorical
10819-3889-31081938890312 BOX in 1 CARTON (10819-3889-3) / 4 TUBE, WITH APPLICATOR in 1 BOX (10819-3889-2) / .75 mL in 1 TUBE, WITH APPLICATOR (10819-3889-1) 12 box2026-03-17NoNoCurrent