FDA.reportPublic FDA data

Povidone-Iodine Gel Swabstick

Product NDC
65517-0036
11-digit product format
655170036
Labeler code
65517
Product ID
65517-0036_43f8fa99-4702-1636-e063-6294a90a6028
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
GEL
Route
TOPICAL
Labeler
Dukal LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-02
Substance
POVIDONE-IODINE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Povidone-Iodine Gel Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/g

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
1300277Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98be29e6-0c9b-22a6-e053-2995a90a9f8cAvailable 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
65517-0036-1Povidone-Iodine Gel Swabstick2.3 g in 1 POUCHGEL2.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-0036POVIDONE-IODINE GEL SWABSTICK (POVIDONE IODINE) GEL [DUKAL LLC]3Current NDC, Legacy NDC, 1 package rows20231014_98be29e6-0c9b-22a6-e053-2995a90a9f8c.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
Povidone-Iodine Gel SwabstickPOVIDONE IODINEDukal LLC98be29e6-0c9b-22a6-e053-2995a90a9f8c2025-11-19WarningsExact identifier
ndc (product): 65517-0036

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300277povidone-iodine gel 10 % Medicated PadPSN98be29e6-0c9b-22a6-e053-2995a90a9f8c4
1300277povidone-iodine 0.1 MG/MG Medicated PadSCD98be29e6-0c9b-22a6-e053-2995a90a9f8c4
1300277povidone-iodine 10 % (titratable iodine 1 % ) Gel SwabstickSY98be29e6-0c9b-22a6-e053-2995a90a9f8c4
1300277povidone-iodine 10 % Gel SwabstickSY98be29e6-0c9b-22a6-e053-2995a90a9f8c4
1300277povidone-iodine 10 % SwabstickSY98be29e6-0c9b-22a6-e053-2995a90a9f8c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-0036-1655170036012.3 g in 1 POUCH (65517-0036-1) 2.3 g2019-12-020000-00-00NoNoCurrent