FDA.reportPublic FDA data

DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC
54305-323
11-digit product format
543050323
Labeler code
54305
Product ID
54305-323_d3750106-10cc-466e-a3cd-87ccfe381fe6
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 HONEY LEMON 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
a535717d-ba55-45e9-9fc3-711b5d7dbf57Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54305-323-192020-02-10DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-262020-02-10DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-192020-01-31DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
54305-323-262020-01-31DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-323-19DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 BAGLOZENGE195
54305-323-26DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC26 in 1 BAGLOZENGE265
54305-323-75DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC175 in 1 BAGLOZENGE1755

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ADUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]1
MENTHOLACTIVE MOIETYL7T10EIP3ADUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]1
HONEYINACTIVE INGREDIENTY9H1V576FHDUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]1
SUCROSEINACTIVE INGREDIENTC151H8M554DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-323DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]5Current NDC, Legacy NDC, 3 package rows20241207_a535717d-ba55-45e9-9fc3-711b5d7dbf57.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 54 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M012
XL-3 Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERnv LLC03210929-331e-462d-b566-4e1865f522462026-01-27WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRnv LLC2381ff41-4584-4b38-839f-f94e733f5bf22026-01-27WarningsExact identifier
application number: M012
Allergy Relief Extra StrengthDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f33c1fb-150b-4083-a9a4-c0fbab4b61332026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
application number: M012
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
application number: M012
good sense nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companyf90bd64a-dd1a-4319-87cd-427d57f677ab2026-01-26WarningsExact identifier
application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu PlusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc547ff880-3d40-4a4a-84ee-cd0d5290a9b92026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Day and Night Cold and FluMAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWAL-MART STORES INCd6a35fb8-1899-4da2-ad2b-0423e332845d2026-01-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINProdose, Inc.7e5de5b0-18f0-4807-8686-da9821f918ce2026-01-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb58b2c36-a403-4dae-b3b2-f0ffd28a963b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc870e6bcb-84ab-45e0-ae57-08a9a182eb0b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inceb8e83a4-981b-48a5-88f4-3a0ba358d3bc2026-01-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc8d2d765f-a7e3-40e6-b35d-0e8806a7ea592026-01-26WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424614menthol 8.3 MG Oral LozengePSNa535717d-ba55-45e9-9fc3-711b5d7dbf575
1424614menthol 8.3 MG Oral LozengeSCDa535717d-ba55-45e9-9fc3-711b5d7dbf575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-323-195430503231919 LOZENGE in 1 BAG (54305-323-19) 19 lozenge2011-04-030000-00-00NoNoCurrent
54305-323-265430503232626 LOZENGE in 1 BAG (54305-323-26) 26 lozenge2011-04-030000-00-00NoNoCurrent
54305-323-7554305032375175 LOZENGE in 1 BAG (54305-323-75) 175 lozenge2020-01-310000-00-00NoNoCurrent