COOL RELIEF ORAL ANESTHETIC

Product NDC
54305-513
11-digit product format
543050513
Labeler code
54305
Product ID
54305-513_688729fc-17f6-4022-82c3-6116973176ba
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola Ag
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

Additional Listing Data#

Finished product
Yes
Brand name base
COOL RELIEF ORAL ANESTHETIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL13.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui2277805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-513-10COOL RELIEF ORAL ANESTHETIC10 in 1 PACKAGELOZENGE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-513COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]3Current NDC, Legacy NDC, 1 package rows20241207_3698a69f-b5c0-4235-8ef8-71c867f1ac0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2277805menthol 13.2 MG Oral LozengePSN3698a69f-b5c0-4235-8ef8-71c867f1ac0d3
2277805menthol 13.2 MG Oral LozengeSCD3698a69f-b5c0-4235-8ef8-71c867f1ac0d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-513-105430505131010 LOZENGE in 1 PACKAGE (54305-513-10) 10 lozenge2020-02-010000-00-00NoNoCurrent