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#

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#

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 71 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Nasal DecongestantPSEUDOEPHEDRINE HCLL. Perrigo Company455b35b4-3969-411b-8036-887615d71e112025-12-21WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact 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