FDA.reportPublic FDA data

NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS

Product NDC
54305-108
11-digit product format
543050108
Labeler code
54305
Product ID
54305-108_ae9b0ace-c22e-4213-a486-b64cd625ec52
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola Ag
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1942-01-01
Substance
MENTHOL
Active strength
2 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
NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 mg/1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54305-108-242020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-242020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-302020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-302020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-502020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-502020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-242020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-242020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-302020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-302020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-502020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
54305-108-502020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-108-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS10 in 1 BAGLOZENGE109
54305-108-24NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS24 in 1 BAGLOZENGE249
54305-108-30NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS30 in 1 BAGLOZENGE309
54305-108-45NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS45 in 1 BAGLOZENGE459
54305-108-50NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS50 in 1 BAGLOZENGE509

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ANATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]2
MENTHOLACTIVE MOIETYL7T10EIP3ANATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RNATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]2
HONEYINACTIVE INGREDIENTY9H1V576FHNATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]2
SUCROSEINACTIVE INGREDIENTC151H8M554NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-108NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]8Current NDC, Legacy NDC, 5 package rows20241207_2006a55d-6af3-4325-a307-bb3c9d8b3cf5.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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
644109menthol 2 MG Oral LozengePSN2006a55d-6af3-4325-a307-bb3c9d8b3cf59
644109menthol 2 MG Oral LozengeSCD2006a55d-6af3-4325-a307-bb3c9d8b3cf59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-108-09543050108099 LOZENGE in 1 BAG (54305-108-09) 9 lozenge2026-01-01NoNoCurrent
54305-108-105430501081010 LOZENGE in 1 BAG (54305-108-10) 10 lozenge1942-01-01NoNoCurrent
54305-108-245430501082424 LOZENGE in 1 BAG (54305-108-24) 24 lozenge1942-01-010000-00-00NoNoCurrent
54305-108-305430501083030 LOZENGE in 1 BAG (54305-108-30) 30 lozenge1942-01-010000-00-00NoNoCurrent
54305-108-455430501084545 LOZENGE in 1 BAG (54305-108-45) 45 lozenge2016-01-01NoNoCurrent
54305-108-505430501085050 LOZENGE in 1 BAG (54305-108-50) 50 lozenge2016-01-010000-00-00NoNoCurrent