Home NDC 42507-963 Antispetic
Product NDC 42507-963
11-digit product format 425070963
Labeler code 42507
Product ID 42507-963_4a04f150-daac-f153-e063-6394a90abebc
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, menthol, methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Hy-Vee, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-05
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 THYMOL .92 mg/mL METHYL SALICYLATE .42 mg/mL MENTHOL .6 mg/mL EUCALYPTOL .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 42507-963-77 Antispetic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 2 42507-963-86 Antispetic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antispetic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Hy-Vee, Inc. 4538029b-1ff9-080a-e063-6394a90ac9b7 2026-02-04 Warnings, Adverse reactions Exact identifier ndc (product): 42507-963
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-963-77 42507096377 500 mL in 1 BOTTLE, PLASTIC (42507-963-77) 500 ml 2025-12-05 No No Current 42507-963-86 42507096386 1000 mL in 1 BOTTLE, PLASTIC (42507-963-86) 1000 ml 2025-12-05 No No Current