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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL15.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-153-19COOL RELIEF ORAL ANESTHETIC19 in 1 BAGLOZENGE196
54305-153-24COOL RELIEF ORAL ANESTHETIC24 in 1 BAGLOZENGE246
54305-153-45COOL RELIEF ORAL ANESTHETIC45 in 1 BAGLOZENGE456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-153COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]6Current NDC, Legacy NDC, 3 package rows20241207_951e9836-e6a3-4094-8a6b-f226c85c897a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-153-195430501531919 LOZENGE in 1 BAG (54305-153-19) 19 lozenge2018-06-010000-00-00NoNoCurrent
54305-153-245430501532424 LOZENGE in 1 BAG (54305-153-24) 24 lozenge2018-06-010000-00-00NoNoCurrent
54305-153-455430501534545 LOZENGE in 1 BAG (54305-153-45) 45 lozenge2018-06-010000-00-00NoNoCurrent