Home NDC 70000-0528-1 Antiseptic
Product NDC 70000-0528
Requested package NDC 70000-0528-1
11-digit product format 700000528
Labeler code 70000
Product ID 70000-0528_498e86aa-1db9-db53-e063-6294a90a7146
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Cardinal Health, 110 dba Leader
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1997-06-15
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 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 70000-0528-1 Antiseptic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0528 ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CARDINAL HEALTH, 110 DBA LEADER] 18 Current NDC, Legacy NDC, 1 package rows 20250507_d176eebb-4870-4206-a52e-f581ecaff400.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 70000-0528-1 70000052801 500 mL in 1 BOTTLE, PLASTIC (70000-0528-1) 500 ml 1997-06-15 0000-00-00 No No Current