betadine

Generic: povidone-iodine

Labeler: atlantis consumer healthcare, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name betadine
Generic Name povidone-iodine
Labeler atlantis consumer healthcare, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/mL

Manufacturer
Atlantis Consumer Healthcare, Inc.

Identifiers & Regulatory

Product NDC 67618-190
Product ID 67618-190_73caf02a-cf17-4097-a1ee-6c3abe87103d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67618190
Hyphenated Format 67618-190

Supplemental Identifiers

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 betadine (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 APPLICATOR in 1 POUCH (67618-190-01) / 1.9 mL in 1 APPLICATOR
  • 3 APPLICATOR in 1 POUCH (67618-190-03) / 1.9 mL in 1 APPLICATOR
  • 25 PACKET in 1 BOX (67618-190-25) / 3 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR
  • 50 PACKET in 1 BOX (67618-190-50) / 1 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR
source: ndc

Packages (4)

67618-190-01 1 APPLICATOR in 1 POUCH (67618-190-01) / 1.9 mL in 1 APPLICATOR 67618-190-03 3 APPLICATOR in 1 POUCH (67618-190-03) / 1.9 mL in 1 APPLICATOR 67618-190-25 25 PACKET in 1 BOX (67618-190-25) / 3 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR 67618-190-50 50 PACKET in 1 BOX (67618-190-50) / 1 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR

Ingredients (1)

povidone-iodine (100 mg/mL)

Linked Drug Pages (1)

Betadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "73caf02a-cf17-4097-a1ee-6c3abe87103d", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "spl_set_id": ["3007da5f-e2ea-4f3a-905c-770782da014e"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Atlantis Consumer Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 POUCH (67618-190-01)  / 1.9 mL in 1 APPLICATOR", "package_ndc": "67618-190-01", "marketing_start_date": "20250701"}, {"sample": false, "description": "3 APPLICATOR in 1 POUCH (67618-190-03)  / 1.9 mL in 1 APPLICATOR", "package_ndc": "67618-190-03", "marketing_start_date": "20250701"}, {"sample": false, "description": "25 PACKET in 1 BOX (67618-190-25)  / 3 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR", "package_ndc": "67618-190-25", "marketing_start_date": "20250701"}, {"sample": false, "description": "50 PACKET in 1 BOX (67618-190-50)  / 1 APPLICATOR in 1 PACKET / 1.9 mL in 1 APPLICATOR", "package_ndc": "67618-190-50", "marketing_start_date": "20250701"}], "brand_name": "Betadine", "product_id": "67618-190_73caf02a-cf17-4097-a1ee-6c3abe87103d", "dosage_form": "SOLUTION", "product_ndc": "67618-190", "generic_name": "POVIDONE-IODINE", "labeler_name": "Atlantis Consumer Healthcare, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Betadine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "100 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}