Home NDC 55319-290 Antiseptic
Product NDC 55319-290
11-digit product format 553190290
Labeler code 55319
Product ID 55319-290_27dff864-d1dc-41f9-a312-d7d1aa66d7cc
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form LIQUID
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-02
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 Antiseptic
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 55319-290-01 Antiseptic 1000 mL in 1 BOTTLE, PLASTIC LIQUID 1000 7 55319-290-25 Antiseptic 250 mL in 1 BOTTLE, PLASTIC LIQUID 250 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-290 ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 2 Current NDC, 2 package rows 20250402_f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea.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 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-290-01 55319029001 1000 mL in 1 BOTTLE, PLASTIC (55319-290-01) 1000 ml 2025-06-02 No No Current 55319-290-25 55319029025 250 mL in 1 BOTTLE, PLASTIC (55319-290-25) 250 ml 2025-06-02 No No Current