FDA.reportPublic FDA data

DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC
63667-234
11-digit product format
636670234
Labeler code
63667
Product ID
63667-234_c838c320-eb3d-4211-92f2-5d97dba03c7e
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola USA Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-01
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
8a6db093-7e52-443f-8dd6-94867606fef8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63667-234-192020-02-10DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
63667-234-262020-02-10DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
63667-234-192020-01-31DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
63667-234-262020-01-31DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-234-19DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 PACKAGELOZENGE195
63667-234-26DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC26 in 1 PACKAGELOZENGE265
63667-234-75DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC175 in 1 PACKAGELOZENGE1755

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-234DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]5Current NDC, Legacy NDC, 3 package rows20241211_8a6db093-7e52-443f-8dd6-94867606fef8.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 68 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cherry throat relief lozengesBENZOCAINEZee Medical499d0748-538f-678c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINNuCare Pharmaceuticals, Inc.46a480c7-7092-b809-e063-6294a90a60cd2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods360a6304-206d-5475-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods36342d8c-34ab-6178-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWinco Foods37244333-1307-5121-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco foods37718c73-880e-4a5c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco Foods40676ddc-577f-5cc9-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLWinco Foods3788e8b6-ab9e-1513-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Martdd31f86b-f59e-459a-8e5f-176828706a4a2025-12-23WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf8e7a08e-7422-4a1b-bfec-93e0b50d10cd2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
application number: M012
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424614menthol 8.3 MG Oral LozengePSN8a6db093-7e52-443f-8dd6-94867606fef85
1424614menthol 8.3 MG Oral LozengeSCD8a6db093-7e52-443f-8dd6-94867606fef85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-234-196366702341919 LOZENGE in 1 PACKAGE (63667-234-19) 19 lozenge2015-05-010000-00-00NoNoCurrent
63667-234-266366702342626 LOZENGE in 1 PACKAGE (63667-234-26) 26 lozenge2015-05-010000-00-00NoNoCurrent
63667-234-7563667023475175 LOZENGE in 1 PACKAGE (63667-234-75) 175 lozenge2020-01-310000-00-00NoNoCurrent