sterile

Generic: povidone-iodine

Labeler: asia dynamics inc., d/b/a adi medical
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sterile
Generic Name povidone-iodine
Labeler asia dynamics inc., d/b/a adi medical
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 g/100g

Manufacturer
Asia Dynamics Inc., d/b/a ADI Medical

Identifiers & Regulatory

Product NDC 83645-552
Product ID 83645-552_2b3618ad-1093-906d-e063-6394a90a7926
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2023-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83645552
Hyphenated Format 83645-552

Supplemental Identifiers

RxCUI
312564
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 sterile (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 g/100g
source: ndc
Packaging
  • 22.5 g in 1 BOTTLE (83645-552-11)
source: ndc

Packages (1)

83645-552-11 22.5 g in 1 BOTTLE (83645-552-11)

Ingredients (1)

povidone-iodine (10 g/100g)

Linked Drug Pages (1)

sterile ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2b3618ad-1093-906d-e063-6394a90a7926", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["0658a0c8-f5ec-b380-e063-6394a90afff5"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Asia Dynamics Inc., d/b/a ADI Medical"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "22.5 g in 1 BOTTLE (83645-552-11)", "package_ndc": "83645-552-11", "marketing_start_date": "20230927"}], "brand_name": "sterile", "product_id": "83645-552_2b3618ad-1093-906d-e063-6394a90a7926", "dosage_form": "SOLUTION", "product_ndc": "83645-552", "generic_name": "POVIDONE-IODINE", "labeler_name": "Asia Dynamics Inc., d/b/a ADI Medical", "product_type": "HUMAN OTC DRUG", "brand_name_base": "sterile", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 g/100g"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230927", "listing_expiration_date": "20261231"}