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 37 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact 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