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 firm2026-10-20

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 101 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
application number: M012
Guaifenesin 400GUAIFENESIN TABLETS 400InvaTech Pharma Solutions LLC40291505-55ca-0759-e063-6394a90acee12025-10-02Exact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsExact identifier
application number: M012
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
application number: M012
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
application number: M012
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
application number: M012
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
application number: M012
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3fa17255-514f-db47-e063-6294a90ae4542025-09-25WarningsExact 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