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 160 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETARGET CORPORATION135d2212-2122-b7a1-e063-6294a90aa5f52024-06-07WarningsExact identifier
application number: M012
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCITARGET Corporatione3da3003-88e3-4431-8b65-e61e177289012024-06-04WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATEFoundation Consumer Healthcare15c3570c-bd00-8e43-e063-6294a90a86832024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare176be362-5237-edd8-e063-6294a90a4aef2024-06-01WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLC682c5a4b-5ded-4276-903f-1ef1141ae5182024-06-01WarningsExact identifier
application number: M012
Maximum Strength Nasal DecongestantOXYMETAZOLINE SPRAYCVS Healthdf1f8bda-7bf3-4755-9169-f2a81d824cbe2024-05-31WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healtha78d29ed-019b-4014-ae6f-c60c75d19c892024-05-31WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact 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