antiseptic

Generic: eucayptol, menthol, methyl salicylate, thymol

Labeler: perrigo direct, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antiseptic
Generic Name eucayptol, menthol, methyl salicylate, thymol
Labeler perrigo direct, inc
Dosage Form MOUTHWASH
Routes
ORAL
Active Ingredients

eucalyptol .92 mg/mL, menthol .42 mg/mL, methyl salicylate .6 mg/mL, thymol .64 mg/mL

Manufacturer
Perrigo Direct, Inc

Identifiers & Regulatory

Product NDC 50804-318
Product ID 50804-318_4b311e75-2780-6a65-e063-6294a90a3127
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 1990-09-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50804318
Hyphenated Format 50804-318

Supplemental Identifiers

RxCUI
1043619
UNII
RV6J6604TK L7T10EIP3A LAV5U5022Y 3J50XA376E

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 antiseptic (source: ndc)
Generic Name eucayptol, menthol, methyl salicylate, thymol (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .92 mg/mL
  • .42 mg/mL
  • .6 mg/mL
  • .64 mg/mL
source: ndc
Packaging
  • 1000 mL in 1 BOTTLE, PLASTIC (50804-318-86)
source: ndc

Packages (1)

50804-318-86 1000 mL in 1 BOTTLE, PLASTIC (50804-318-86)

Ingredients (4)

eucalyptol (.92 mg/mL) menthol (.42 mg/mL) methyl salicylate (.6 mg/mL) thymol (.64 mg/mL)

Linked Drug Pages (1)

Antiseptic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b311e75-2780-6a65-e063-6294a90a3127", "openfda": {"unii": ["RV6J6604TK", "L7T10EIP3A", "LAV5U5022Y", "3J50XA376E"], "rxcui": ["1043619"], "spl_set_id": ["50776776-80aa-4098-8cf3-6daa0b305b15"], "manufacturer_name": ["Perrigo Direct, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (50804-318-86)", "package_ndc": "50804-318-86", "marketing_start_date": "19900915"}], "brand_name": "Antiseptic", "product_id": "50804-318_4b311e75-2780-6a65-e063-6294a90a3127", "dosage_form": "MOUTHWASH", "product_ndc": "50804-318", "generic_name": "Eucayptol, menthol, methyl salicylate, thymol", "labeler_name": "Perrigo Direct, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic", "active_ingredients": [{"name": "EUCALYPTOL", "strength": ".92 mg/mL"}, {"name": "MENTHOL", "strength": ".42 mg/mL"}, {"name": "METHYL SALICYLATE", "strength": ".6 mg/mL"}, {"name": "THYMOL", "strength": ".64 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19900915", "listing_expiration_date": "20271231"}