Home NDC 71165-012 Freegells Cough Drops Menthol Eucalyptus
Product NDC 71165-012
11-digit product format 711650012
Labeler code 71165
Product ID 71165-012_08a1d725-5476-d285-e063-6294a90addc0
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 2022-10-01
Substance MENTHOL
Active strength 5.4 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 Freegells Cough Drops Menthol Eucalyptus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5.4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485287 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71165-012-00 Freegells Cough Drops Menthol Eucalyptus 30 in 1 BAG LOZENGE 30 2 71165-012-01 Freegells Cough Drops Menthol Eucalyptus 80 in 1 BAG LOZENGE 80 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71165-012 FREEGELLS COUGH DROPS MENTHOL EUCALYPTUS (MENTHOL) LOZENGE [RICLAN S.A.] 2 Current NDC, Legacy NDC, 2 package rows 20231027_1141593a-f3ba-4adf-b332-f9fcb0b5a013.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 74 of 180 · 3,583 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 71165-012-00 71165001200 30 LOZENGE in 1 BAG (71165-012-00) 30 lozenge 2022-10-01 0000-00-00 No No Current 71165-012-01 71165001201 80 LOZENGE in 1 BAG (71165-012-01) 80 lozenge 2022-10-01 0000-00-00 No No Current