saninta 10% povidone-iodine

Generic: povidone-iodine solution

Labeler: ll pharma
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 ll pharma
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/mL

Manufacturer
LL Pharma

Identifiers & Regulatory

Product NDC 81351-004
Product ID 81351-004_47446355-315f-6485-e063-6294a90a0377
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Marketing Start 2021-08-25
Marketing End 2029-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81351004
Hyphenated Format 81351-004

Supplemental Identifiers

RxCUI
797730
UPC
0628634499061
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 (81351-004-01) / 2.3 mL in 1 APPLICATOR
  • 22.5 mL in 1 PACKET (81351-004-02)
source: ndc

Packages (2)

81351-004-01 3 APPLICATOR in 1 POUCH (81351-004-01) / 2.3 mL in 1 APPLICATOR 81351-004-02 22.5 mL in 1 PACKET (81351-004-02)

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": "47446355-315f-6485-e063-6294a90a0377", "openfda": {"nui": ["N0000175486", "M0011640"], "upc": ["0628634499061"], "unii": ["85H0HZU99M"], "rxcui": ["797730"], "spl_set_id": ["bd344007-895e-30d6-e053-2a95a90a019d"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["LL Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 APPLICATOR in 1 POUCH (81351-004-01)  / 2.3 mL in 1 APPLICATOR", "package_ndc": "81351-004-01", "marketing_end_date": "20290731", "marketing_start_date": "20210825"}, {"sample": false, "description": "22.5 mL in 1 PACKET (81351-004-02)", "package_ndc": "81351-004-02", "marketing_end_date": "20290930", "marketing_start_date": "20210825"}], "brand_name": "Saninta 10% Povidone-Iodine", "product_id": "81351-004_47446355-315f-6485-e063-6294a90a0377", "dosage_form": "LIQUID", "product_ndc": "81351-004", "generic_name": "Povidone-Iodine Solution", "labeler_name": "LL Pharma", "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_end_date": "20290930", "marketing_start_date": "20210825"}