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 SPRAY
Routes
TOPICAL
Active Ingredients

povidone-iodine 5 mg/mL

Manufacturer
Atlantis Consumer Healthcare, Inc.

Identifiers & Regulatory

Product NDC 67618-160
Product ID 67618-160_043f3c0e-36f5-440a-81b7-6bf5c0b52020
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Marketing Start 1992-04-15
Marketing End 2026-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67618160
Hyphenated Format 67618-160

Supplemental Identifiers

RxCUI
108204 238850
UPC
0367618160039
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
  • 5 mg/mL
source: ndc
Packaging
  • 89 mL in 1 BOTTLE (67618-160-03)
source: ndc

Packages (1)

67618-160-03 89 mL in 1 BOTTLE (67618-160-03)

Ingredients (1)

povidone-iodine (5 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": "043f3c0e-36f5-440a-81b7-6bf5c0b52020", "openfda": {"nui": ["N0000175486", "M0011640"], "upc": ["0367618160039"], "unii": ["85H0HZU99M"], "rxcui": ["108204", "238850"], "spl_set_id": ["f9939dca-cd07-3200-a95b-177a771585af"], "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": "89 mL in 1 BOTTLE (67618-160-03)", "package_ndc": "67618-160-03", "marketing_end_date": "20260930", "marketing_start_date": "19920415"}], "brand_name": "Betadine", "product_id": "67618-160_043f3c0e-36f5-440a-81b7-6bf5c0b52020", "dosage_form": "SPRAY", "product_ndc": "67618-160", "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": "5 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260930", "marketing_start_date": "19920415"}