aplicare

Generic: povidone-iodine

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

Drug Facts

Product Profile

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

povidone-iodine 10 mg/mL

Manufacturer
Aplicare Products LLC

Identifiers & Regulatory

Product NDC 52380-0138
Product ID 52380-0138_4640ae81-0ef8-0677-e063-6394a90a5a89
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 523800138
Hyphenated Format 52380-0138

Supplemental Identifiers

RxCUI
1300277
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 (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
  • 1 APPLICATOR in 1 POUCH (52380-0138-1) / 2.4 mL in 1 APPLICATOR
  • 50 POUCH in 1 BOX (52380-0138-2) / 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR
source: ndc

Packages (2)

52380-0138-1 1 APPLICATOR in 1 POUCH (52380-0138-1) / 2.4 mL in 1 APPLICATOR 52380-0138-2 50 POUCH in 1 BOX (52380-0138-2) / 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR

Ingredients (1)

povidone-iodine (10 mg/mL)

Linked Drug Pages (1)

Aplicare ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4640ae81-0ef8-0677-e063-6394a90a5a89", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["1300277"], "spl_set_id": ["0a48b8ef-f2d6-ed50-e063-6394a90a8ebe"], "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": "1 APPLICATOR in 1 POUCH (52380-0138-1)  / 2.4 mL in 1 APPLICATOR", "package_ndc": "52380-0138-1", "marketing_start_date": "20240901"}, {"sample": false, "description": "50 POUCH in 1 BOX (52380-0138-2)  / 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR", "package_ndc": "52380-0138-2", "marketing_start_date": "20240901"}], "brand_name": "Aplicare", "product_id": "52380-0138_4640ae81-0ef8-0677-e063-6394a90a5a89", "dosage_form": "SWAB", "product_ndc": "52380-0138", "generic_name": "Povidone-Iodine", "labeler_name": "Aplicare Products LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aplicare", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}