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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui797730

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

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