Home NDC 50804-664-12 Antispetic
Product NDC 50804-664
Requested package NDC 50804-664-12
11-digit product format 508040664
Labeler code 50804
Product ID 50804-664_4b313926-26e6-69d9-e063-6394a90a5db0
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Perrigo Direct, Inc�
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-10-01
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 50804-664-12 Antispetic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 23 50804-664-13 Antispetic 1250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1250 23 50804-664-69 Antispetic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 23 50804-664-86 Antispetic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PERRIGO DIRECT INC.] 21 Current NDC, Legacy NDC, 4 package rows 20250503_cb4cf304-4f19-40cd-b480-9d89d1909684.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 50804-664-12 50804066412 1500 mL in 1 BOTTLE, PLASTIC (50804-664-12) 1500 ml 1992-10-01 0000-00-00 No No Current