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 114 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
application number: M012
Diphenhydramine HCL STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
application number: M012
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalmart Inc.35da8429-1f83-9e81-e063-6294a90a35152025-05-23WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
application number: M012
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
application number: M012
Quality Choice NasalOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION3833e781-f6ee-4c6d-8756-d8ea2293a1f22025-05-19WarningsExact identifier
application number: M012
Quality Choice Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd45e99e5-ce66-4458-8d23-63a5dc7ae5092025-05-19WarningsExact identifier
application number: M012
Quality Choicel Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION460f0cc1-6a85-4d79-af87-a94fd151769e2025-05-19WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC812a093f-cf83-4f7a-927a-1b5695be7f902025-05-19WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAkron Pharma Inc.79a6b8c7-0e81-4a46-a854-31f4490427092025-05-16WarningsExact 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