antiseptic mouth rinse

Generic: eucalyptol, menthol, methyl salicylate, thymol

Labeler: h e b
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 h e b
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
H E B

Identifiers & Regulatory

Product NDC 37808-318
Product ID 37808-318_4a9014de-51a1-319c-e063-6394a90a4632
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2009-05-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808318
Hyphenated Format 37808-318

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 (37808-318-12)
  • 500 mL in 1 BOTTLE, PLASTIC (37808-318-77)
  • 1000 mL in 1 BOTTLE, PLASTIC (37808-318-86)
source: ndc

Packages (3)

37808-318-12 1500 mL in 1 BOTTLE, PLASTIC (37808-318-12) 37808-318-77 500 mL in 1 BOTTLE, PLASTIC (37808-318-77) 37808-318-86 1000 mL in 1 BOTTLE, PLASTIC (37808-318-86)

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": "4a9014de-51a1-319c-e063-6394a90a4632", "openfda": {"unii": ["RV6J6604TK", "L7T10EIP3A", "LAV5U5022Y", "3J50XA376E"], "rxcui": ["1043619"], "spl_set_id": ["8ba4382d-1a88-4a8d-9d40-c0f38cfd01a5"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1500 mL in 1 BOTTLE, PLASTIC (37808-318-12)", "package_ndc": "37808-318-12", "marketing_start_date": "20090521"}, {"sample": false, "description": "500 mL in 1 BOTTLE, PLASTIC (37808-318-77)", "package_ndc": "37808-318-77", "marketing_start_date": "20090521"}, {"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (37808-318-86)", "package_ndc": "37808-318-86", "marketing_start_date": "20090521"}], "brand_name": "Antiseptic Mouth Rinse", "product_id": "37808-318_4a9014de-51a1-319c-e063-6394a90a4632", "dosage_form": "MOUTHWASH", "product_ndc": "37808-318", "generic_name": "Eucalyptol, Menthol, Methyl salicylate, Thymol", "labeler_name": "H E B", "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": "20090521", "listing_expiration_date": "20271231"}