saninta 10% povidone-iodine

Generic: povidone-iodine solution

Labeler: lernapharm
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name saninta 10% povidone-iodine
Generic Name povidone-iodine solution
Labeler lernapharm
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/mL

Manufacturer
Lernapharm

Identifiers & Regulatory

Product NDC 68356-601
Product ID 68356-601_26edf53b-4ba3-a69b-e063-6294a90a1769
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68356601
Hyphenated Format 68356-601

Supplemental Identifiers

RxCUI
797730
UPC
0896180012519 0896180012496 0896180012502
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 saninta 10% povidone-iodine (source: ndc)
Generic Name povidone-iodine solution (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 3 APPLICATOR in 1 POUCH (68356-601-01) / 2.3 mL in 1 APPLICATOR
  • 22.5 mL in 1 PACKET (68356-601-02)
  • 15 mL in 1 PACKET (68356-601-03)
source: ndc

Packages (3)

68356-601-01 3 APPLICATOR in 1 POUCH (68356-601-01) / 2.3 mL in 1 APPLICATOR 68356-601-02 22.5 mL in 1 PACKET (68356-601-02) 68356-601-03 15 mL in 1 PACKET (68356-601-03)

Ingredients (1)

povidone-iodine (100 mg/mL)

Linked Drug Pages (1)

Saninta 10% Povidone-Iodine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "26edf53b-4ba3-a69b-e063-6294a90a1769", "openfda": {"nui": ["N0000175486", "M0011640"], "upc": ["0896180012519", "0896180012496", "0896180012502"], "unii": ["85H0HZU99M"], "rxcui": ["797730"], "spl_set_id": ["1275efa3-0602-2f17-e063-6394a90ac56e"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Lernapharm"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 APPLICATOR in 1 POUCH (68356-601-01)  / 2.3 mL in 1 APPLICATOR", "package_ndc": "68356-601-01", "marketing_start_date": "20240226"}, {"sample": false, "description": "22.5 mL in 1 PACKET (68356-601-02)", "package_ndc": "68356-601-02", "marketing_start_date": "20240226"}, {"sample": false, "description": "15 mL in 1 PACKET (68356-601-03)", "package_ndc": "68356-601-03", "marketing_start_date": "20241114"}], "brand_name": "Saninta 10% Povidone-Iodine", "product_id": "68356-601_26edf53b-4ba3-a69b-e063-6294a90a1769", "dosage_form": "LIQUID", "product_ndc": "68356-601", "generic_name": "Povidone-Iodine Solution", "labeler_name": "Lernapharm", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Saninta 10% Povidone-Iodine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "100 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}