RICOLA MAX NASAL CARE COOL MENTHOL

Product NDC
54305-206
11-digit product format
543050206
Labeler code
54305
Product ID
54305-206_4de120a2-06be-4995-8231-2b58ccbeb079
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola Ag
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
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
RICOLA MAX NASAL CARE COOL MENTHOL
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2599614Internal RxNorm lookup
2599616Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfecd10f-adbe-4be7-854d-f9f202fef145Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-206-34RICOLA MAX NASAL CARE COOL MENTHOL34 in 1 BAGLOZENGE343

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-206RICOLA MAX NASAL CARE COOL MENTHOL (MENTHOL) LOZENGE [RICOLA AG]3Current NDC, Legacy NDC, 1 package rows20241207_dfecd10f-adbe-4be7-854d-f9f202fef145.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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599614menthol 15.3 MG Oral LozengePSNdfecd10f-adbe-4be7-854d-f9f202fef1453
2599616Ricola 15.3 MG Oral LozengePSNdfecd10f-adbe-4be7-854d-f9f202fef1453
2599616menthol 15.3 MG Oral Lozenge [Ricola]SBDdfecd10f-adbe-4be7-854d-f9f202fef1453
2599614menthol 15.3 MG Oral LozengeSCDdfecd10f-adbe-4be7-854d-f9f202fef1453
2599616Ricola 15.3 MG Oral LozengeSYdfecd10f-adbe-4be7-854d-f9f202fef1453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-206-345430502063434 LOZENGE in 1 BAG (54305-206-34) 34 lozenge2022-03-010000-00-00NoNoCurrent