prep solution topical antiseptic microbicide

Generic: povidone-iodine

Labeler: degasa sa de cv
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name prep solution topical antiseptic microbicide
Generic Name povidone-iodine
Labeler degasa sa de cv
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/mL

Manufacturer
Degasa SA De CV

Identifiers & Regulatory

Product NDC 67326-350
Product ID 67326-350_097358e0-eaba-c991-e063-6294a90acb81
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2007-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67326350
Hyphenated Format 67326-350

Supplemental Identifiers

RxCUI
312564
UPC
7501048350810
UNII
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 prep solution topical antiseptic microbicide (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 948 mL in 1 BOTTLE (67326-350-04)
  • 59 mL in 1 BOTTLE (67326-350-05)
  • 118 mL in 1 BOTTLE (67326-350-06)
  • 237 mL in 1 BOTTLE (67326-350-07)
  • 474 mL in 1 BOTTLE (67326-350-08)
  • 3785 mL in 1 JUG (67326-350-09)
  • 89 mL in 1 BOTTLE (67326-350-10)
source: ndc

Packages (7)

67326-350-04 948 mL in 1 BOTTLE (67326-350-04) 67326-350-05 59 mL in 1 BOTTLE (67326-350-05) 67326-350-06 118 mL in 1 BOTTLE (67326-350-06) 67326-350-07 237 mL in 1 BOTTLE (67326-350-07) 67326-350-08 474 mL in 1 BOTTLE (67326-350-08) 67326-350-09 3785 mL in 1 JUG (67326-350-09) 67326-350-10 89 mL in 1 BOTTLE (67326-350-10)

Ingredients (1)

povidone-iodine (100 mg/mL)

Linked Drug Pages (1)

Prep Solution Topical Antiseptic Microbicide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "097358e0-eaba-c991-e063-6294a90acb81", "openfda": {"nui": ["N0000175486", "M0011640"], "upc": ["7501048350810"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["dd34cc57-8a8c-4189-b517-61448f961c9e"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Degasa SA De CV"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "948 mL in 1 BOTTLE (67326-350-04)", "package_ndc": "67326-350-04", "marketing_start_date": "20070101"}, {"sample": false, "description": "59 mL in 1 BOTTLE (67326-350-05)", "package_ndc": "67326-350-05", "marketing_start_date": "20110314"}, {"sample": false, "description": "118 mL in 1 BOTTLE (67326-350-06)", "package_ndc": "67326-350-06", "marketing_start_date": "20070101"}, {"sample": false, "description": "237 mL in 1 BOTTLE (67326-350-07)", "package_ndc": "67326-350-07", "marketing_start_date": "20070101"}, {"sample": false, "description": "474 mL in 1 BOTTLE (67326-350-08)", "package_ndc": "67326-350-08", "marketing_start_date": "20070101"}, {"sample": false, "description": "3785 mL in 1 JUG (67326-350-09)", "package_ndc": "67326-350-09", "marketing_start_date": "20070101"}, {"sample": false, "description": "89 mL in 1 BOTTLE (67326-350-10)", "package_ndc": "67326-350-10", "marketing_start_date": "20161117"}], "brand_name": "Prep Solution Topical Antiseptic Microbicide", "product_id": "67326-350_097358e0-eaba-c991-e063-6294a90acb81", "dosage_form": "SOLUTION", "product_ndc": "67326-350", "generic_name": "POVIDONE-IODINE", "labeler_name": "Degasa SA De CV", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Prep Solution", "brand_name_suffix": "Topical Antiseptic Microbicide", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "100 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20070101", "listing_expiration_date": "20261231"}