Home NDC 67860-664-69 Antispetic
Product NDC 67860-664
Requested package NDC 67860-664-69
11-digit product format 678600664
Labeler code 67860
Product ID 67860-664_498ebfd5-9068-7bac-e063-6394a90a107d
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Cariba International
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-08
Substance EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Antispetic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EUCALYPTOL .92 mg/mL MENTHOL .42 mg/mL METHYL SALICYLATE .6 mg/mL THYMOL .64 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043619 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67860-664-69 Antispetic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 16 67860-664-86 Antispetic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67860-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CARIBA INTERNATIONAL] 14 Current NDC, Legacy NDC, 2 package rows 20250429_035e82fc-75eb-474d-88ce-771e60e62179.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67860-664-69 67860066469 250 mL in 1 BOTTLE, PLASTIC (67860-664-69) 250 ml 2016-11-08 0000-00-00 No No Current