FDA.reportPublic FDA data

MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC
63667-185
11-digit product format
636670185
Labeler code
63667
Product ID
63667-185_701df832-b48f-45c2-a696-7da04a79c56d
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
2015-09-01
Substance
MENTHOL
Active strength
4.8 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
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637119Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b640a5d2-a7fe-486d-a65f-e7c993f950d6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63667-185-192020-02-10MOUNTAIN HERB SUGAR FREE WITH STEVIA
63667-185-452020-02-10MOUNTAIN HERB SUGAR FREE WITH STEVIA
63667-185-192020-01-31MOUNTAIN HERB SUGAR FREE WITH STEVIA
63667-185-452020-01-31MOUNTAIN HERB SUGAR FREE WITH STEVIA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-185-19MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 PACKAGELOZENGE195
63667-185-45MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC45 in 1 PACKAGELOZENGE455

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1
ISOMALTINACTIVE INGREDIENTS870P55O2WMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1
REBAUDIOSIDE AINACTIVE INGREDIENTB3FUD0528FMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-185MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20241211_b640a5d2-a7fe-486d-a65f-e7c993f950d6.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 66 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact identifier
application number: M012
Sorbutuss NRSORBUTUSSDextrum Laboratories Inc.304f1d5a-218c-51ae-e054-00144ff88e882025-12-26WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a28aa-00e9-8b9d-e063-6394a90ace2a2025-12-26WarningsExact identifier
application number: M012
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f4a026-c4d2-2645-e063-6294a90aac582025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a13b5-6fcb-70ed-e063-6394a90a7fb32025-12-26WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a4802-7c02-ccce-e063-6394a90ad71d2025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749f353-9286-15b9-e063-6394a90a76932025-12-26WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
application number: M012
TUSSIN CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAptaPharma Inc.c005c6cf-7891-463e-b65d-1129ad4bf6ec2025-12-26WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAptaPharma Inc.b2cef61f-ab54-4a20-a7f7-6d3da4754e8b2025-12-26WarningsExact identifier
application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVORDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAptaPharma Inc.9ae6fe74-80cd-482a-b3b9-3acafd6708ec2025-12-26WarningsExact identifier
application number: M012
Tussin ExpectorantGUAIFENESINAptaPharma, Inc.ca8fa216-09c1-42b2-a95b-fa3d0f13363c2025-12-26WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC3b7e0ee7-4dda-4bbe-842c-6cbbc208acd52025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f2025-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637119menthol 4.8 MG Oral LozengePSNb640a5d2-a7fe-486d-a65f-e7c993f950d65
637119menthol 4.8 MG Oral LozengeSCDb640a5d2-a7fe-486d-a65f-e7c993f950d65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-185-196366701851919 LOZENGE in 1 PACKAGE (63667-185-19) 19 lozenge2015-09-010000-00-00NoNoCurrent
63667-185-456366701854545 LOZENGE in 1 PACKAGE (63667-185-45) 45 lozenge2015-09-010000-00-00NoNoCurrent