Home NDC 54305-156 COOL RELIEF LEMON FROST ORAL ANESTHETIC
Product NDC 54305-156
11-digit product format 543050156
Labeler code 54305
Product ID 54305-156_c40349c5-4746-4318-9f9b-68d60668a9f2
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LOZENGE
Route ORAL
Labeler Ricola Ag
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-01
Substance MENTHOL
Active strength 16 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 LEMON FROST ORAL ANESTHETIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2122215 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54305-156-19 COOL RELIEF LEMON FROST ORAL ANESTHETIC 19 in 1 BAG LOZENGE 19 3 54305-156-24 COOL RELIEF LEMON FROST ORAL ANESTHETIC 24 in 1 BAG LOZENGE 24 3 54305-156-45 COOL RELIEF LEMON FROST ORAL ANESTHETIC 45 in 1 BAG LOZENGE 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54305-156 COOL RELIEF LEMON FROST ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG] 3 Current NDC, Legacy NDC, 3 package rows 20241207_908f5ce5-94a4-4c35-ae7a-b308ea37fa08.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.
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 54305-156-19 54305015619 19 LOZENGE in 1 BAG (54305-156-19) 19 lozenge 2019-04-01 0000-00-00 No No Current 54305-156-24 54305015624 24 LOZENGE in 1 BAG (54305-156-24) 24 lozenge 2019-04-01 0000-00-00 No No Current 54305-156-45 54305015645 45 LOZENGE in 1 BAG (54305-156-45) 45 lozenge 2019-04-01 0000-00-00 No No Current