FDA.reportPublic FDA data

CliniClean Povidone-Iodine Solution Antiseptic

Product NDC
69464-801
Requested package NDC
69464-801-75
11-digit product format
694640801
Labeler code
69464
Product ID
69464-801_155c6599-cef8-97d5-e063-6394a90ae20c
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
LIQUID
Route
TOPICAL
Labeler
HR HealthCare
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
POVIDONE-IODINE
Active strength
100 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
CliniClean Povidone-Iodine Solution Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbf1ac4d-0ff8-4cf9-ab3b-729dac33ccdaAvailable 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
69464-801-75CliniClean Povidone-Iodine Solution Antiseptic23 g in 1 POUCHLIQUID231

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69464-801CLINICLEAN POVIDONE-IODINE SOLUTION ANTISEPTIC (POVIDONE-IODINE) LIQUID [HR HEALTHCARE]1Current NDC, 1 package rows20240406_dbf1ac4d-0ff8-4cf9-ab3b-729dac33ccda.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
CliniClean Povidone-Iodine Solution AntisepticPOVIDONE-IODINEHR HealthCaredbf1ac4d-0ff8-4cf9-ab3b-729dac33ccda2024-04-05WarningsExact identifier
ndc (package): 69464-801-75
ndc (product): 69464-801
ndc11 (package): 69464080175

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNdbf1ac4d-0ff8-4cf9-ab3b-729dac33ccda1
312564povidone-iodine 100 MG/ML Topical SolutionSCDdbf1ac4d-0ff8-4cf9-ab3b-729dac33ccda1
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYdbf1ac4d-0ff8-4cf9-ab3b-729dac33ccda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69464-801-756946408017523 g in 1 POUCH (69464-801-75) 23 g2024-03-01NoNoCurrent