FDA.reportPublic FDA data

Gems

Product NDC
71165-173
11-digit product format
711650173
Labeler code
71165
Product ID
71165-173_314a1d6b-394d-49cd-81b7-3d7b232b4cd6
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
8.4 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
Menthol Eucalyptus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.4 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-173-02GemsMenthol Eucalyptus9 in 1 PACKAGELOZENGE96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-173GEMS MENTHOL EUCALYPTUS (MENTHOL) LOZENGE [RICLAN S.A.]5Current NDC, Legacy NDC, 1 package rows20240921_853254be-2d3b-46a8-97b9-8532f771a828.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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGENc499574c-f32b-4608-bf8b-51ad44e357252026-07-13WarningsExact identifier
application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLAMERISOURCE BERGENf442c61b-7d2c-401c-b862-acbe2282927b2026-07-13WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINAMERISOURCE BERGEN0269c0fd-0d8f-4264-9025-d4dcb3c45c602026-07-13WarningsExact identifier
application number: M012
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
application number: M012
Sinus Pressure and Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLRite Aid Corporation35bcf263-3296-4d9c-84c0-146a173d6e872026-07-13WarningsExact identifier
application number: M012
Good Neighbor Childrens Cough Relief Cherry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGENa8e2fd43-b801-41ae-8d79-8ecf4a7715432026-07-13WarningsExact identifier
application number: M012
Good Neighbor No Drip Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGEN7872aadd-b23c-431f-8048-24eece25ca2d2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGEN404a3521-8340-4476-a068-0e69cd0e514f2026-07-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
application number: M012
Good Neighbor Long Acting Cough Adult TussinDEXTROMETHORPHAN HBRAMERISOURCE BERGENdf3c76bd-bd5b-42d7-a5f1-560fd3cba6462026-07-13WarningsExact identifier
application number: M012
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGENa217ca8a-1c00-4816-bc26-cc0f71c80c902026-07-13WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
application number: M012
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
application number: M012
Severe Congestion and Cough Multi-Symptom Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy707eb066-cdfc-444b-833a-9d6d133d48e42026-07-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311512menthol 8.4 MG Oral LozengePSN853254be-2d3b-46a8-97b9-8532f771a8286
311512menthol 8.4 MG Oral LozengeSCD853254be-2d3b-46a8-97b9-8532f771a8286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71165-173-02711650173029 LOZENGE in 1 PACKAGE (71165-173-02) 9 lozenge2021-09-130000-00-00NoNoCurrent