aplicare povidone-iodine

Generic: povidone-iodine

Labeler: aplicare products, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name aplicare povidone-iodine
Generic Name povidone-iodine
Labeler aplicare products, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 mg/mL

Manufacturer
Aplicare Products, LLC

Identifiers & Regulatory

Product NDC 52380-1905
Product ID 52380-1905_4640bac3-a3f1-ba7f-e063-6294a90a66ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 1998-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 523801905
Hyphenated Format 52380-1905

Supplemental Identifiers

RxCUI
312564 617973
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 aplicare povidone-iodine (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE, SPRAY (52380-1905-0)
  • 90 mL in 1 BOTTLE (52380-1905-3)
source: ndc

Packages (2)

52380-1905-0 60 mL in 1 BOTTLE, SPRAY (52380-1905-0) 52380-1905-3 90 mL in 1 BOTTLE (52380-1905-3)

Ingredients (1)

povidone-iodine (10 mg/mL)

Linked Drug Pages (1)

Aplicare Povidone-Iodine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4640bac3-a3f1-ba7f-e063-6294a90a66ea", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312564", "617973"], "spl_set_id": ["7302a2f8-a600-4200-bc4e-309e4c190fe5"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Aplicare Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE, SPRAY (52380-1905-0)", "package_ndc": "52380-1905-0", "marketing_start_date": "19980901"}, {"sample": false, "description": "90 mL in 1 BOTTLE (52380-1905-3)", "package_ndc": "52380-1905-3", "marketing_start_date": "19980901"}], "brand_name": "Aplicare Povidone-Iodine", "product_id": "52380-1905_4640bac3-a3f1-ba7f-e063-6294a90a66ea", "dosage_form": "SOLUTION", "product_ndc": "52380-1905", "generic_name": "Povidone-Iodine", "labeler_name": "Aplicare Products, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aplicare Povidone-Iodine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980901", "listing_expiration_date": "20261231"}