Gems

Product NDC
71165-171
11-digit product format
711650171
Labeler code
71165
Product ID
71165-171_6a91187e-0204-47bd-b67d-6d2eb7f22467
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
9 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
Honey Lemon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL9 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-171-02GemsHoney Lemon9 in 1 PACKAGELOZENGE96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-171GEMS HONEY LEMON (MENTHOL) LOZENGE [RICLAN S.A.]5Current NDC, Legacy NDC, 1 package rows20240921_639f1419-18f7-4413-9d0f-74caf388bca5.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 82 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid GelsACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.20ae92d9-fbc6-5b7a-e063-6294a90a15c32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51c44970-06e5-082e-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.54236151-37db-0b5a-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.52542774-fd05-640c-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dca689-e4a0-5526-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f2d18f6-935f-9215-e053-2a91aa0aedd32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6fb28fa1-ebbb-64bf-e053-2991aa0a1de42025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5213ca7f-5a78-6471-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f7ba256-ed14-5fe0-e053-2a91aa0aacc12025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.6f7bf92d-4aaf-86e0-e053-2991aa0a2d912025-12-04WarningsExact identifier
application number: M012
Afrin NoDrip Allergy Sinus NightOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.b023a571-7e54-7c63-e053-2a95a90a0f782025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEBayer HealthCare LLC.b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d2025-12-04WarningsExact identifier
application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3231869-8ddf-9d17-e053-2995a90ae6d52025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Multi Symptom FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ae7cf41e-b618-d6bb-e053-2a95a90a66922025-12-04WarningsExact identifier
application number: M012
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold, Cough and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.351d3c5c-05c8-921a-e063-6394a90abef92025-12-04WarningsExact identifier
application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e4f3f906-2252-21d1-e053-2a95a90a85df2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569961menthol 9 MG Oral LozengePSN639f1419-18f7-4413-9d0f-74caf388bca56
2569961menthol 9 MG Oral LozengeSCD639f1419-18f7-4413-9d0f-74caf388bca56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71165-171-02711650171029 LOZENGE in 1 PACKAGE (71165-171-02) 9 lozenge2021-09-130000-00-00NoNoCurrent