FDA.reportPublic FDA data

Gems

Product NDC
71165-172
11-digit product format
711650172
Labeler code
71165
Product ID
71165-172_5b2396e7-b307-4b16-bfd2-1b95c209d03e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Riclan S.A.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-13
Substance
MENTHOL
Active strength
7 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
Gems
Brand name suffix
Cherry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-172-02GemsCherry9 in 1 PACKAGELOZENGE96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-172GEMS CHERRY (MENTHOL) LOZENGE [RICLAN S.A.]5Current NDC, Legacy NDC, 1 package rows20240921_c86ca25a-363e-4712-b177-41c781124a81.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 97 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
application number: M012
TexaClear Pain and Chest Congestion ReliefCHOLINE SALICYLATE,GUAIFENESINGM Pharmaceuticals, INC672bc78a-2c71-4135-b64a-2b8c40ac688c2025-10-13WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLRejoice International Corp.33d1fbf3-d33c-58b9-e063-6294a90ae0982025-10-13WarningsExact identifier
application number: M012
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCdb81e32b-0cad-400b-8479-a3b51de92b122025-10-10WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852ceea2-d6a1-6de2-e053-2a91aa0ad50d2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
application number: M012
Giltuss Diabetic Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
application number: M012
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
application number: M012
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8b2c847-25e9-8714-e053-2995a90a73ce2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253015menthol 7 MG Oral LozengePSNc86ca25a-363e-4712-b177-41c781124a816
253015menthol 7 MG Oral LozengeSCDc86ca25a-363e-4712-b177-41c781124a816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71165-172-02711650172029 LOZENGE in 1 PACKAGE (71165-172-02) 9 lozenge2021-09-130000-00-00NoNoCurrent