FDA.reportPublic FDA data

Prep Solution

Product NDC
67326-350
Requested package NDC
67326-350-04
11-digit product format
673260350
Labeler code
67326
Product ID
67326-350_097358e0-eaba-c991-e063-6294a90acb81
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Degasa SA De CV
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prep Solution
Brand name suffix
Topical Antiseptic Microbicide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE100 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
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
dd34cc57-8a8c-4189-b517-61448f961c9eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67326-350-04Prep Solution Topical Antiseptic Microbicide948 mL in 1 BOTTLESOLUTION9486
67326-350-05Prep Solution Topical Antiseptic Microbicide59 mL in 1 BOTTLESOLUTION596
67326-350-06Prep Solution Topical Antiseptic Microbicide118 mL in 1 BOTTLESOLUTION1186
67326-350-07Prep Solution Topical Antiseptic Microbicide237 mL in 1 BOTTLESOLUTION2376
67326-350-08Prep Solution Topical Antiseptic Microbicide474 mL in 1 BOTTLESOLUTION4746
67326-350-09Prep Solution Topical Antiseptic Microbicide3785 mL in 1 JUGSOLUTION37856
67326-350-10Prep Solution Topical Antiseptic Microbicide89 mL in 1 BOTTLESOLUTION896

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Povidone-IodineACTIVE INGREDIENT85H0HZU99MPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
IodineACTIVE MOIETY9679TC07X4PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
Citric AcidINACTIVE INGREDIENT2968PHW8QPPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1
WaterINACTIVE INGREDIENT059QF0KO0RPREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67326-350PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE (POVIDONE-IODINE) SOLUTION [DEGASA SA DE CV]6Current NDC, Legacy NDC, 7 package rows20231106_dd34cc57-8a8c-4189-b517-61448f961c9e.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
Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEDegasa SA De CVdd34cc57-8a8c-4189-b517-61448f961c9e2023-11-05WarningsExact identifier
ndc (package): 67326-350-04
ndc (product): 67326-350
ndc11 (package): 67326035004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNdd34cc57-8a8c-4189-b517-61448f961c9e6
312564povidone-iodine 100 MG/ML Topical SolutionSCDdd34cc57-8a8c-4189-b517-61448f961c9e6
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYdd34cc57-8a8c-4189-b517-61448f961c9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67326-350-0467326035004948 mL in 1 BOTTLE (67326-350-04) 948 ml2007-01-010000-00-00NoNoCurrent