DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC
54305-331
11-digit product format
543050331
Labeler code
54305
Product ID
54305-331_25d63830-f7f9-4e3a-a45f-0280a04d6d31
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
8.5 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
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.5 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
1232117Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
984c9793-163c-4b97-b244-9b471966a122Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-331-19DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 BAGLOZENGE198
54305-331-26DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC26 in 1 BAGLOZENGE268
54305-331-75DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC175 in 1 BAGLOZENGE1758

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-331DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]8Current NDC, Legacy NDC, 3 package rows20241207_984c9793-163c-4b97-b244-9b471966a122.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 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Relief Cough Cherry LiquidDEXTROMETHORPHAN HBR, GUAIFENSINTopco Associates3170748e-b09f-4c07-9927-df43771166c52025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e70d0784-53bc-4910-aade-3c9ad6e364412025-12-16WarningsExact identifier
application number: M012
Pain and SinusACETAMINOPHEN AND PHENYLEPHRINEJHK Inc dba American Safety & First Aid88f86f5a-cc2b-4c75-b7a4-f2021922280b2025-12-16WarningsExact identifier
application number: M012
Severe Congestion and Cough, Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Companyb75af815-9bd4-4a7a-bc68-f42f4af506992025-12-16WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fe5fd29e-7f81-4633-8c3b-010d68abe7012025-12-16WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLCe0a62fa1-9f8a-4770-b28b-1f4f02a762e02025-12-16WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company8c4b59b8-dfab-4f4a-9966-f07b026a758a2025-12-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)df866cf6-0526-4e61-ac9b-245b57dd5df62025-12-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensc89200b6-4adb-452e-b931-07f631dad6412025-12-16WarningsExact identifier
application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.45fa9159-d74c-063a-e063-6294a90a3ed02025-12-15WarningsExact identifier
application number: M012
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf2b2467f-2d9b-4742-b90a-95975c3b694f2025-12-13WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLHEB39178eb7-ada9-30bf-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLHEB3a443179-b7a6-3242-e054-00144ff8d46c2025-12-13WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLHEB39bd0ca1-348f-0ce1-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLHEB766236e2-3302-2232-e053-2991aa0af5032025-12-13WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLHEB3a30a427-6ab4-24ae-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough LozengesBENZOCAINEHEB3063ea93-6bc2-1d18-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
HEB Menthol Cough DropsMENTHOLHEBc197855d-15b4-38fc-e053-2a95a90a2dc72025-12-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232117menthol 8.5 MG Oral LozengePSN984c9793-163c-4b97-b244-9b471966a1228
1232117menthol 8.5 MG Oral LozengeSCD984c9793-163c-4b97-b244-9b471966a1228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-331-195430503311919 LOZENGE in 1 BAG (54305-331-19) 19 lozenge2011-04-030000-00-00NoNoCurrent
54305-331-265430503312626 LOZENGE in 1 BAG (54305-331-26) 26 lozenge2011-04-030000-00-00NoNoCurrent
54305-331-7554305033175175 LOZENGE in 1 BAG (54305-331-75) 175 lozenge2011-04-030000-00-00NoNoCurrent