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
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 HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration
2026-12-31

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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
application number: M012
SKAPEMED ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a208a1f-f6e8-0b4a-e063-6294a90a10c82026-07-21WarningsExact identifier
application number: M012
SERYNTH FAST RELIEF NASALNAPHAZOLINE HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4abdc0-aded-1b8a-e063-6394a90a9b562026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d0c03-7d8f-76cb-e063-6394a90a938c2026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
application number: M012
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
application number: M012
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC17639c3b-5d36-41f5-bd0d-da29075abd092026-07-21WarningsExact identifier
application number: M012
NATUHEAL ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a470b9e-c83f-fb20-e063-6294a90a2f132026-07-20WarningsExact identifier
application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1c444202-19e9-8d04-e063-6394a90a92942026-07-20WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)40e0b17a-5704-4203-8f0a-11b2fcf81f8f2026-07-17WarningsExact identifier
application number: M012
Equate Daytime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.ee1ef41d-b8be-42f3-9918-ccf1c0a802412026-07-17WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsExact identifier
application number: M012
BEST CHOICE No DripALLERGY SINUSBEST CHOICE (VALU MERCHANDISERS COMPANY)d5f95b56-8201-4d97-82ab-e23761bfe7202026-07-17WarningsExact identifier
application number: M012
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsExact identifier
application number: M012
Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0839c07b-f692-4af1-85b8-da60fb281d492026-07-17WarningsExact 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