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 13 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
application number: M012
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
application number: M012
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsExact identifier
application number: M012
RIGHT REMEDIES Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrive Pharmaceuticals Inc.51c4dcfb-8725-d547-e063-6394a90ac04c2026-07-31WarningsExact identifier
application number: M012
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
application number: M012
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
application number: M012
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
application number: M012
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsExact identifier
application number: M012
Sinus Relief Daytime, NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation352b89b5-6995-4873-a103-e8f89074fdc92026-07-30WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Incf1e83e43-011c-4470-bd55-fb2818a9fc842026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
TOPCARE NITE TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d2026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact 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