Home NDC 54305-153 COOL RELIEF ORAL ANESTHETIC
Product NDC 54305-153
11-digit product format 543050153
Labeler code 54305
Product ID 54305-153_b19f8bc7-1e7c-4eed-a20c-cab9fa8929f4
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LOZENGE
Route ORAL
Labeler Ricola Ag
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-01
Substance MENTHOL
Active strength 15.3 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 COOL RELIEF ORAL ANESTHETIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 15.3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54305-153-19 COOL RELIEF ORAL ANESTHETIC 19 in 1 BAG LOZENGE 19 6 54305-153-24 COOL RELIEF ORAL ANESTHETIC 24 in 1 BAG LOZENGE 24 6 54305-153-45 COOL RELIEF ORAL ANESTHETIC 45 in 1 BAG LOZENGE 45 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54305-153 COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG] 6 Current NDC, Legacy NDC, 3 package rows 20241207_951e9836-e6a3-4094-8a6b-f226c85c897a.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 14 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54305-153-19 54305015319 19 LOZENGE in 1 BAG (54305-153-19) 19 lozenge 2018-06-01 0000-00-00 No No Current 54305-153-24 54305015324 24 LOZENGE in 1 BAG (54305-153-24) 24 lozenge 2018-06-01 0000-00-00 No No Current 54305-153-45 54305015345 45 LOZENGE in 1 BAG (54305-153-45) 45 lozenge 2018-06-01 0000-00-00 No No Current