FDA.reportPublic FDA data

Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops

Product NDC
63667-960
11-digit product format
636670960
Labeler code
63667
Product ID
63667-960_3936f7f7-67e2-48a3-ae63-23a3c1dd6fcb
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
1942-01-01
Substance
MENTHOL
Active strength
3.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63667-96063667-960-30DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Lemon with Echinacea Cough Suppressant Throat Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3.5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63667-960-192020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-192020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-242020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-242020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-302020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-302020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-452020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-452020-02-10NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-192020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-192020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-242020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-242020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-302020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-302020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-452020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS
63667-960-452020-01-31NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-960-19Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops19 in 1 BAGLOZENGE198
63667-960-24Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops24 in 1 BAGLOZENGE248
63667-960-30Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops30 in 1 BAGLOZENGE308
63667-960-45Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops45 in 1 BAGLOZENGE458

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ANATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
MENTHOLACTIVE MOIETYL7T10EIP3ANATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
HONEYINACTIVE INGREDIENTY9H1V576FHNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
LEMON JUICEINACTIVE INGREDIENTAGN709ANTJNATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-960NATURAL HONEY LEMON WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]8Current NDC, Legacy NDC, 4 package rows20241211_43c3d42c-b033-4548-8e2c-1903fc556e1b.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 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433195menthol 3.5 MG Oral LozengePSN43c3d42c-b033-4548-8e2c-1903fc556e1b8
433195menthol 3.5 MG Oral LozengeSCD43c3d42c-b033-4548-8e2c-1903fc556e1b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-960-1563667096015115 LOZENGE in 1 BAG (63667-960-15) 115 lozenge2026-01-01NoNoCurrent
63667-960-196366709601919 LOZENGE in 1 BAG (63667-960-19) 19 lozenge2016-01-010000-00-00NoNoCurrent
63667-960-246366709602424 LOZENGE in 1 BAG (63667-960-24) 24 lozenge1942-01-010000-00-00NoNoCurrent
63667-960-306366709603030 in 1 BAGHistorical
63667-960-456366709604545 LOZENGE in 1 BAG (63667-960-45) 45 lozenge1942-01-010000-00-00NoNoCurrent