Home NDC 63667-513 COOL RELIEF ORAL ANESTHETIC
Product NDC 63667-513
11-digit product format 636670513
Labeler code 63667
Product ID 63667-513_c1038250-ebbe-4fd8-a0f0-030a9209d7ff
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LOZENGE
Route ORAL
Labeler Ricola USA Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
Substance MENTHOL
Active strength 13.2 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 13.2 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 2277805 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 63667-513-10 COOL RELIEF ORAL ANESTHETIC 10 in 1 PACKAGE LOZENGE 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63667-513 COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241211_d66f47a9-35ab-4bf9-8065-c81abcb503f5.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 29 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 63667-513-10 63667051310 10 LOZENGE in 1 PACKAGE (63667-513-10) 10 lozenge 2020-02-01 0000-00-00 No No Current