purprep

Generic: povidone iodine and isopropyl alcohol

Labeler: carefusion 213 llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name purprep
Generic Name povidone iodine and isopropyl alcohol
Labeler carefusion 213 llc
Dosage Form SPONGE
Routes
TOPICAL
Active Ingredients

isopropyl alcohol 725 mg/mL, povidone-iodine 8.3 mg/mL

Manufacturer
CareFusion 213 LLC

Identifiers & Regulatory

Product NDC 54365-014
Product ID 54365-014_40add5c5-68aa-96f9-e063-6294a90a7282
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2020-04-09

Pharmacologic Class

Established (EPC)
antiseptic [epc]
Chemical Structure
iodine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54365014
Hyphenated Format 54365-014

Supplemental Identifiers

RxCUI
1052725
UNII
ND2M416302 85H0HZU99M
NUI
N0000175486 M0011640

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name purprep (source: ndc)
Generic Name povidone iodine and isopropyl alcohol (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 725 mg/mL
  • 8.3 mg/mL
source: ndc
Packaging
  • 1 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATOR
  • 1 APPLICATOR in 1 POUCH (54365-014-42) / 26 mL in 1 APPLICATOR
source: ndc

Packages (2)

54365-014-41 1 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATOR 54365-014-42 1 APPLICATOR in 1 POUCH (54365-014-42) / 26 mL in 1 APPLICATOR

Ingredients (2)

isopropyl alcohol (725 mg/mL) povidone-iodine (8.3 mg/mL)

Linked Drug Pages (1)

PurPrep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "40add5c5-68aa-96f9-e063-6294a90a7282", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["ND2M416302", "85H0HZU99M"], "rxcui": ["1052725"], "spl_set_id": ["a1c6e118-7861-c8d0-e053-2995a90aeaaa"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["CareFusion 213 LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 POUCH (54365-014-41)  / 10.5 mL in 1 APPLICATOR", "package_ndc": "54365-014-41", "marketing_start_date": "20200521"}, {"sample": false, "description": "1 APPLICATOR in 1 POUCH (54365-014-42)  / 26 mL in 1 APPLICATOR", "package_ndc": "54365-014-42", "marketing_start_date": "20200409"}], "brand_name": "PurPrep", "product_id": "54365-014_40add5c5-68aa-96f9-e063-6294a90a7282", "dosage_form": "SPONGE", "product_ndc": "54365-014", "generic_name": "povidone iodine and isopropyl alcohol", "labeler_name": "CareFusion 213 LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PurPrep", "active_ingredients": [{"name": "ISOPROPYL ALCOHOL", "strength": "725 mg/mL"}, {"name": "POVIDONE-IODINE", "strength": "8.3 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200409", "listing_expiration_date": "20261231"}