betadine gargle

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 gargle
Generic Name povidone-iodine
Labeler atlantis consumer healthcare, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

povidone-iodine .05 mg/mL

Manufacturer
Atlantis Consumer Healthcare, Inc.

Identifiers & Regulatory

Product NDC 67618-181
Product ID 67618-181_803ae961-c01c-4910-91f7-4f668956d3ad
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2027-12-31
Marketing Start 2020-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67618181
Hyphenated Format 67618-181

Supplemental Identifiers

RxCUI
314935 2374363
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 gargle (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (67618-181-08) / 237 mL in 1 BOTTLE
  • 2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

67618-181-08 1 BOTTLE in 1 CARTON (67618-181-08) / 237 mL in 1 BOTTLE 67618-181-16 2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE

Ingredients (1)

povidone-iodine (.05 mg/mL)

Linked Drug Pages (1)

Betadine Gargle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "803ae961-c01c-4910-91f7-4f668956d3ad", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["314935", "2374363"], "spl_set_id": ["5f0a3377-1398-2603-c632-f0d214bb88ec"], "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 BOTTLE in 1 CARTON (67618-181-08)  / 237 mL in 1 BOTTLE", "package_ndc": "67618-181-08", "marketing_start_date": "20200615"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (67618-181-16)  / 237 mL in 1 BOTTLE", "package_ndc": "67618-181-16", "marketing_start_date": "20231228"}], "brand_name": "Betadine Gargle", "product_id": "67618-181_803ae961-c01c-4910-91f7-4f668956d3ad", "dosage_form": "SOLUTION", "product_ndc": "67618-181", "generic_name": "POVIDONE-IODINE", "labeler_name": "Atlantis Consumer Healthcare, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Betadine Gargle", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": ".05 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200615", "listing_expiration_date": "20271231"}