FDA.reportPublic FDA data

Cough Drops Gems Flawless Cherry Flavor 30ct

Product NDC
71165-032
Requested package NDC
71165-032-01
11-digit product format
711650032
Labeler code
71165
Product ID
71165-032_43e13006-4c54-ace0-e063-6394a90a6816
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
2025-05-01
Substance
LEVOMENTHOL
Active strength
7 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Cough Drops Gems Flawless Cherry Flavor 30ct
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMENTHOL7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BZ1R15MTK7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f0260df-89ac-4b83-afea-3aff56ff1b43Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-032-01Cough Drops Gems Flawless Cherry Flavor 30ct9 in 1 CARTONLOZENGE92
71165-032-01Cough Drops Gems Flawless Cherry Flavor 30ct30 in 1 BAGLOZENGE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-032COUGH DROPS GEMS FLAWLESS CHERRY FLAVOR 30CT (MENTHOL) LOZENGE [RICLAN S.A.]1Current NDC, 2 package rows20250515_0f0260df-89ac-4b83-afea-3aff56ff1b43.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 120 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC131b1f17-cd86-f9b3-e063-6294a90a30282025-02-12WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates, LLC17d0dbc7-c8c2-7917-e063-6394a90a42af2025-02-12WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEKroger Companybc00bbf8-52bb-fa75-e053-2a95a90a94062025-02-11WarningsExact identifier
application number: M012
Daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELSTIME CAP LABORATORIES, INC.fd24653e-c4fa-3c09-e053-6394a90aaa9e2025-02-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELSTIME CAP LABORATORIES INC.fd81dd4b-9617-f4c1-e053-6394a90a5e722025-02-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDOLGENCORP, LLCbe2207b7-b8f8-7fba-e053-2a95a90abd162025-02-10WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEKroger Companybc0115a3-5322-855d-e053-2995a90aba272025-02-10WarningsExact identifier
application number: M012
Day time high blood pressure cold and fluACETAMINOPHEN DEXTROMETHORPHAN HBRCamber Consumer Care09fbd872-0970-4864-9308-4a7b859839202025-02-10WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf05e11ce-c908-acbc-e053-2a95a90a584e2025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf035c499-cda6-fadf-e053-2995a90af4572025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6d977ce-bbca-f1cc-e053-6394a90acc962025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da36d3-496d-2336-e053-6394a90a0f832025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da2e02-42c7-1ede-e053-6394a90aff5f2025-02-09WarningsExact identifier
application number: M012
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
application number: M012
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
application number: M012
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
application number: M012
SofSkin Vaporizing Chest Rub and Cough SuppressantCAMPHOR, MENTHOL, EUCALYPTUS OILViny Health and Beauty Inc34626cf5-64fc-15c0-e063-6294a90aa3102025-02-04WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY, INC17922df7-7867-4300-bd99-55aee7b606062025-02-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healthf4b8ff54-47b5-4d18-bf4e-b101abb22a242025-02-03WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71165-032-01711650032019 BAG in 1 CARTON (71165-032-01) / 30 LOZENGE in 1 BAG9 bag2025-05-01NoNoCurrent