FDA.reportPublic FDA data

NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS

Product NDC
63667-954
11-digit product format
636670954
Labeler code
63667
Product ID
63667-954_ac4e93eb-1fb1-48ce-804c-3633e6955b74
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
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
63667-954-242020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-242020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-302020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-302020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-502020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-502020-02-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-242020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-242020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-302020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-302020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-502020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS
63667-954-502020-01-31NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-954-10NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS10 in 1 BAGLOZENGE1011
63667-954-24NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS24 in 1 BAGLOZENGE2411
63667-954-30NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS30 in 1 BAGLOZENGE3011
63667-954-45NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS45 in 1 BAGLOZENGE4511
63667-954-50NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS50 in 1 BAGLOZENGE5011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ANATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3ANATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]4
CARAMELINACTIVE INGREDIENTT9D99G2B1RNATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]4
HONEYINACTIVE INGREDIENTY9H1V576FHNATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-954NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]10Current NDC, Legacy NDC, 5 package rows20241211_bb166b96-e8f6-4c58-a667-1de71cf42120.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 30 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM MaxDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC6a8cdcad-4881-49b8-a3f1-2c1574300d182026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry FlavorGUAIFENESINReckitt Benckiser LLC8ec74cf2-88f5-40be-87e2-b756ab8417542026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc16253d3-3824-458c-8840-e3a2fbe7682c2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1991d5ee-fc90-4070-8965-cd6f4abc45cf2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa25278bd-c3b9-4db3-b4f7-b395eb5f91772026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba2cc08-acad-79a8-e063-6394a90af17f2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa3523aa3-9ed1-472d-9986-438440d0a3eb2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC2ed3c844-0532-40d9-beba-738d196de34d2026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift SinusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC6189fb89-a7d7-4ae6-a9e8-d9512acc0f552026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa51b6312-598e-4a25-a873-6b59bc87d9002026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC1e243dbe-138f-4346-ba22-ceea01e970522026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa14bc0d1-9b05-4a21-aaa8-95d4d073b9ed2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC128f3442-9802-4303-80be-aead092379362026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC41b8cead-92a0-47d8-8079-4fb5d18bf2492026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC33f0d9bb-c67d-92ba-e063-6294a90a99432026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum StrengthACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2c01962d-74e3-4dfa-b7cb-a91a687711d52026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCf5365c6d-9296-41a5-953a-d1008954e67f2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8905706b-b9da-4520-8cf2-87d7c125edf32026-05-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
644109menthol 2 MG Oral LozengePSNbb166b96-e8f6-4c58-a667-1de71cf4212011
644109menthol 2 MG Oral LozengeSCDbb166b96-e8f6-4c58-a667-1de71cf4212011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-954-09636670954099 LOZENGE in 1 BAG (63667-954-09) 9 lozenge2026-01-01NoNoCurrent
63667-954-106366709541010 LOZENGE in 1 BAG (63667-954-10) 10 lozenge1942-01-01NoNoCurrent
63667-954-246366709542424 LOZENGE in 1 BAG (63667-954-24) 24 lozenge1942-01-010000-00-00NoNoCurrent
63667-954-306366709543030 LOZENGE in 1 BAG (63667-954-30) 30 lozenge1942-01-010000-00-00NoNoCurrent
63667-954-456366709544545 LOZENGE in 1 BAG (63667-954-45) 45 lozenge2016-01-01NoNoCurrent
63667-954-506366709545050 LOZENGE in 1 BAG (63667-954-50) 50 lozenge2016-01-010000-00-00NoNoCurrent