FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL15.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
951e9836-e6a3-4094-8a6b-f226c85c897aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54305-153-192020-02-10DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-242020-02-10DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-452020-02-10DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-192020-01-31DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-242020-01-31DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-452020-01-31DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

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

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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.39f64f10-f442-45a9-a060-9f99e78c678d2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.ed5a294a-fc03-43dd-825d-23a2320609002025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.be558e5b-cf35-4035-a69c-8d66deeac6b22025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.a2591a96-ed66-45b1-abf6-6b26d0bb4f442025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.efe92e48-5086-4b61-a298-0d8ceefe100e2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.1d6a1182-ab63-460a-ab91-8d4c2ae5d01e2025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e1db79a4-4a24-4c3f-9ee9-2af3f876ac962025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.d3b6669e-479f-4bc1-b533-5e9a0cc652132025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e42a22ef-1035-4dd0-94b0-43625542d5842025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.3dca05de-cf63-4ca0-88be-473ea637e6b42025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.d6149dfd-f2a5-4bbd-913c-6a95efe5ffd22025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.c6eda1de-4490-4a28-8a31-cbf3e102e74e2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc4261cd90-5087-44a3-bef9-72d33dbf0dfd2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Ince70240a8-fa9d-4005-a3a0-5cca6188bf612025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incfda3d254-e103-4be9-9086-51ad022b2b3f2025-01-09WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalc161da79-9ea5-4c7f-890c-4315129fe5bf2025-01-08WarningsExact identifier
application number: M022

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