FDA.reportPublic FDA data

PurPrep

Product NDC
54365-014
11-digit product format
543650014
Labeler code
54365
Product ID
54365-014_40add5c5-68aa-96f9-e063-6294a90a7282
Type
HUMAN OTC DRUG
Nonproprietary name
povidone iodine and isopropyl alcohol
Dosage form
SPONGE
Route
TOPICAL
Labeler
CareFusion 213 LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-09
Substance
ISOPROPYL ALCOHOL; POVIDONE-IODINE
Active strength
725; 8.3 mg/mL; 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
PurPrep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL725 mg/mL
POVIDONE-IODINE8.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302, 85H0HZU99M
Rxcui1052725

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
54365-014-41PurPrep1 in 1 POUCHSPONGE112
54365-014-41PurPrep10.5 mL in 1 APPLICATORSPONGE10.512
54365-014-42PurPrep26 mL in 1 APPLICATORSPONGE2612
54365-014-42PurPrep1 in 1 POUCHSPONGE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54365-014PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL) SPONGE [CAREFUSION 213 LLC]11Current NDC, Legacy NDC, 4 package rows20241106_a1c6e118-7861-c8d0-e053-2995a90aeaaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052725povidone-iodine 8.3 % / isopropyl alcohol 72.5 % Topical SolutionPSNa1c6e118-7861-c8d0-e053-2995a90aeaaa12
1052725isopropyl alcohol 0.725 ML/ML / povidone-iodine 83 MG/ML Topical SolutionSCDa1c6e118-7861-c8d0-e053-2995a90aeaaa12
1052725isopropyl alcohol 72.5 % / povidone-iodine 8.3 % Topical SolutionSYa1c6e118-7861-c8d0-e053-2995a90aeaaa12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54365-014-41543650014411 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATOR1 applicator2020-05-210000-00-00NoNoCurrent
54365-014-42543650014421 APPLICATOR in 1 POUCH (54365-014-42) / 26 mL in 1 APPLICATOR1 applicator2020-04-090000-00-00NoNoCurrent