DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC
54305-313
11-digit product format
543050313
Labeler code
54305
Product ID
54305-313_298e8140-8f87-43fc-a9f8-87cd39cbfda6
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola Ag
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-03
Substance
MENTHOL
Active strength
8.3 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.3 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1424614Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
71ca8af7-172d-40da-be1e-ff3ab5568e74Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-313-19DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 BAGLOZENGE195
54305-313-26DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC26 in 1 BAGLOZENGE265
54305-313-75DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC175 in 1 BAGLOZENGE1755

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-313DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]5Current NDC, Legacy NDC, 3 package rows20241207_71ca8af7-172d-40da-be1e-ff3ab5568e74.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 131 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
application number: M012
Adult Allergy ReliefCALMCO ALLERGY RELIEFCalmCo08288825-0f38-b6a3-e063-6394a90aa3582024-12-07WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola Agc142663f-086e-4ab7-a758-9107d70775372024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag984c9793-163c-4b97-b244-9b471966a1222024-12-05WarningsExact identifier
application number: M012
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
application number: M012
Cold Multi Symptom Daytime NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Associationd5cbb5b0-564c-429e-b680-fa683e7963932024-12-05WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCarede8a623f-7b10-4d56-a74b-3737e7716ffe2024-12-05WarningsExact identifier
application number: M012
Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC9773958b-c5e5-4da7-a8e9-6b6c223a2b302024-12-05WarningsExact identifier
application number: M012
Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC399e0e51-c2a7-451c-b74d-d3db140cef692024-12-05WarningsExact identifier
application number: M012
Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI09531edc-8dbd-451f-ae02-f922e9e8c2482024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag71ca8af7-172d-40da-be1e-ff3ab5568e742024-12-05WarningsExact identifier
application number: M012
ndc (product): 54305-313
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Agb790a91c-33be-4bc3-bdeb-eae6f366f0852024-12-05WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola Agea42e516-2ef8-41c9-ae4e-571f0147bc6b2024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola Ag8b2d5c0f-509e-447d-b071-d73c4785f1202024-12-05WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Ag8ae0e21a-44a0-4a2c-9880-54eeeaea07ea2024-12-05WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag6d82469b-d51c-4824-9830-6c1874ad4fe42024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola Age8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce52024-12-05WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Aga535717d-ba55-45e9-9fc3-711b5d7dbf572024-12-05WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola Ag4330ee8d-0b37-4a93-886b-5fc6e6598da72024-12-05WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9de99931-31ef-79e2-e053-2a95a90a98ad2024-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424614menthol 8.3 MG Oral LozengePSN71ca8af7-172d-40da-be1e-ff3ab5568e745
1424614menthol 8.3 MG Oral LozengeSCD71ca8af7-172d-40da-be1e-ff3ab5568e745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-313-195430503131919 LOZENGE in 1 BAG (54305-313-19) 19 lozenge2011-04-030000-00-00NoNoCurrent
54305-313-265430503132626 LOZENGE in 1 BAG (54305-313-26) 26 lozenge2011-04-030000-00-00NoNoCurrent
54305-313-7554305031375175 LOZENGE in 1 BAG (54305-313-75) 175 lozenge2011-04-030000-00-00NoNoCurrent