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 157 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb8927b-22c5-2ca3-e063-6294a90aa5632024-08-02WarningsExact identifier
application number: M012
No Drip Severe Anefrin Nasal0.05% OXYMETAZOLINE HCLWalgreens Companyc126e969-56f3-47b4-a011-02ff150eccb82024-08-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation90e0426b-654f-4bcd-8b1d-cf56d1fc0c682024-07-27WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HCLA-S Medication Solutions0e81a937-59e5-4869-8ffb-c758fb37230d2024-07-23WarningsExact identifier
application number: M012
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
application number: M012
Night Time Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1f3eeb6c-4c44-4e2a-ad72-12c95e6589c92024-07-22WarningsExact identifier
application number: M012
CareOne Childrens Allergy ReliefDIPHENHYDRAMINE HCLAmerican Sales Companybb78ef2c-4f42-4e8f-b38d-f9b2965a384b2024-07-19WarningsExact identifier
application number: M012
dg health allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, LLC71445443-34bd-4d8c-b9c8-e7c3b8d4c8322024-07-19WarningsExact identifier
application number: M012
basic care childrens allergy reliefDIPHENHYDRAMINE HCLAmazon.com Services LLC75b9ee90-ad26-433e-8b90-97441b8d1e152024-07-19WarningsExact identifier
application number: M012
Cold and Flu Severe Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC9b74dd00-8f84-4fce-b5ea-df886b5953262024-07-18WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
application number: M012
equate allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb05acd16-21cb-4ee0-afa0-8f7d591664352024-07-18WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLPublix Super Markets Inccc6e4e26-84f5-4003-b1eb-f0e06d3e294e2024-07-18WarningsExact identifier
application number: M012
childrens allergyDIPHENHYDRAMINE HYDROCHLORIDEKroger Company10ebc7f8-dc8a-4640-8f87-d0d073998fd52024-07-18WarningsExact 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