Home NDC 71165-171 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 Ingredient Strength MENTHOL 9 mg/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71165-171-02 GemsHoney Lemon 9 in 1 PACKAGE LOZENGE 9 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71165-171 GEMS HONEY LEMON (MENTHOL) LOZENGE [RICLAN S.A.] 5 Current NDC, Legacy NDC, 1 package rows 20240921_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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71165-171-02 71165017102 9 LOZENGE in 1 PACKAGE (71165-171-02) 9 lozenge 2021-09-13 0000-00-00 No No Current