Home NDC 11344-664-12 Antispetic
Product NDC 11344-664
Requested package NDC 11344-664-12
11-digit product format 113440664
Labeler code 11344
Product ID 11344-664_5259f5c3-2a76-a2e7-e063-6394a90a4643
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Nice-Pak Products, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-07-15
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 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 11344-664-12 Antispetic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 6 11344-664-69 Antispetic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 6 11344-664-77 Antispetic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 6 11344-664-86 Antispetic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC] 4 Current NDC, 4 package rows 20250514_da4a0e82-b97e-4515-98c6-2c998164a247.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 Sample Exclude flag Status 11344-664-12 11344066412 1500 mL in 1 BOTTLE, PLASTIC (11344-664-12) 1500 ml 1992-07-15 No No Current