antiseptic mouth rinse

Generic: eucalyptol, menthol, methyl salicylate, thymol

Labeler: demoulas super markets, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antiseptic mouth rinse
Generic Name eucalyptol, menthol, methyl salicylate, thymol
Labeler demoulas super markets, 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
Demoulas Super Markets, Inc

Identifiers & Regulatory

Product NDC 53942-318
Product ID 53942-318_49f012c0-9a19-b4e5-e063-6394a90aa93f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 1990-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53942318
Hyphenated Format 53942-318

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 mouth rinse (source: ndc)
Generic Name eucalyptol, 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
  • 1500 mL in 1 BOTTLE, PLASTIC (53942-318-12)
  • 1000 mL in 1 BOTTLE, PLASTIC (53942-318-86)
source: ndc

Packages (2)

53942-318-12 1500 mL in 1 BOTTLE, PLASTIC (53942-318-12) 53942-318-86 1000 mL in 1 BOTTLE, PLASTIC (53942-318-86)

Ingredients (4)

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

Linked Drug Pages (1)

Antiseptic Mouth Rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49f012c0-9a19-b4e5-e063-6394a90aa93f", "openfda": {"unii": ["RV6J6604TK", "L7T10EIP3A", "LAV5U5022Y", "3J50XA376E"], "rxcui": ["1043619"], "spl_set_id": ["37e9f40c-dff3-4185-abad-889e97ee4fcf"], "manufacturer_name": ["Demoulas Super Markets, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1500 mL in 1 BOTTLE, PLASTIC (53942-318-12)", "package_ndc": "53942-318-12", "marketing_start_date": "19900715"}, {"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (53942-318-86)", "package_ndc": "53942-318-86", "marketing_start_date": "19900715"}], "brand_name": "Antiseptic Mouth Rinse", "product_id": "53942-318_49f012c0-9a19-b4e5-e063-6394a90aa93f", "dosage_form": "MOUTHWASH", "product_ndc": "53942-318", "generic_name": "Eucalyptol, Menthol, Methyl Salicylate, Thymol", "labeler_name": "Demoulas Super Markets, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic Mouth Rinse", "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": "19900715", "listing_expiration_date": "20271231"}