maximum strength betadine clear

Generic: benzalkonium cl and pramoxine hcl

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

Drug Facts

Product Profile

Brand Name maximum strength betadine clear
Generic Name benzalkonium cl and pramoxine hcl
Labeler atlantis consumer healthcare, inc.
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .13 mg/mL, pramoxine hydrochloride 1 mg/mL

Manufacturer
Atlantis Consumer Healthcare, Inc.

Identifiers & Regulatory

Product NDC 67618-183
Product ID 67618-183_3a3f54a7-c041-83d1-e063-6294a90aaa51
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2023-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67618183
Hyphenated Format 67618-183

Supplemental Identifiers

UPC
0367618183069
UNII
F5UM2KM3W7 88AYB867L5

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 maximum strength betadine clear (source: ndc)
Generic Name benzalkonium cl and pramoxine hcl (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .13 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (67618-183-06)
source: ndc

Packages (1)

67618-183-06 177 mL in 1 BOTTLE (67618-183-06)

Ingredients (2)

benzalkonium chloride (.13 mg/mL) pramoxine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Maximum Strength Betadine Clear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3a3f54a7-c041-83d1-e063-6294a90aaa51", "openfda": {"upc": ["0367618183069"], "unii": ["F5UM2KM3W7", "88AYB867L5"], "spl_set_id": ["31b94a76-1536-47c0-ab03-e487c2625c58"], "manufacturer_name": ["Atlantis Consumer Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (67618-183-06)", "package_ndc": "67618-183-06", "marketing_start_date": "20231222"}], "brand_name": "Maximum Strength Betadine Clear", "product_id": "67618-183_3a3f54a7-c041-83d1-e063-6294a90aaa51", "dosage_form": "SPRAY", "product_ndc": "67618-183", "generic_name": "Benzalkonium Cl and Pramoxine HCl", "labeler_name": "Atlantis Consumer Healthcare, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Maximum Strength Betadine Clear", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".13 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231222", "listing_expiration_date": "20261231"}