FDA.reportPublic FDA data

Profend Nasal Decolonization

Product NDC
10819-3888
11-digit product format
108193888
Labeler code
10819
Product ID
10819-3888_40312dd9-3553-cdfb-e063-6394a90a3638
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
2018-02-16
Marketing end
2028-10-31
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Profend Nasal Decolonization

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6245b1e5-6637-18bc-e053-2a91aa0aa981Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10819-3888-32024-02-05C16284748780-11030e365-03d1-111a-e063-dadaa90a10e2Profend Nasal Decolonization Kit
10819-3888-32024-01-30C16284748780-11030e365-03d1-111a-e063-dadaa90a10e2Profend Nasal Decolonization Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-3888-1Profend Nasal Decolonization0.75 mL in 1 TUBE, WITH APPLICATORSWAB0.7512
10819-3888-2Profend Nasal Decolonization4 in 1 BOXSWAB412
10819-3888-3Profend Nasal Decolonization12 in 1 CARTONSWAB1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10819-3888-1EA - Each10819-3888f45d24af-157e-4b33-ae7c-7e6196fbd85512024-04-05
10819-3888-2EA - Each10819-3888a1a6c16e-5711-4245-8660-9d559cc8e0b612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-3888PROFEND NASAL DECOLONIZATION (POVIDONE IODINE USP, 10% W/W) SWAB [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]10Current NDC, Legacy NDC, 3 package rows20250210_6245b1e5-6637-18bc-e053-2a91aa0aa981.zip

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 DecolonizationPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.6245b1e5-6637-18bc-e053-2a91aa0aa9812025-10-02WarningsExact identifier
ndc (product): 10819-3888

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN6245b1e5-6637-18bc-e053-2a91aa0aa98112
797730povidone-iodine 100 MG/ML Medicated PadSCD6245b1e5-6637-18bc-e053-2a91aa0aa98112
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY6245b1e5-6637-18bc-e053-2a91aa0aa98112
797730povidone-iodine 10 % Medicated PadSY6245b1e5-6637-18bc-e053-2a91aa0aa98112
797730povidone-iodine 10 % Medicated SwabstickSY6245b1e5-6637-18bc-e053-2a91aa0aa98112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10819-3888-1108193888010.75 mL in 1 TUBE, WITH APPLICATOR0.75 mlHistorical
10819-3888-2108193888024 in 1 BOXHistorical
10819-3888-31081938880312 BOX in 1 CARTON (10819-3888-3) / 4 TUBE, WITH APPLICATOR in 1 BOX (10819-3888-2) / .75 mL in 1 TUBE, WITH APPLICATOR (10819-3888-1) 12 box2018-02-162028-10-31NoNoCurrent