Home NDC 54305-323 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
Product NDC 54305-323
11-digit product format 543050323
Labeler code 54305
Product ID 54305-323_d3750106-10cc-466e-a3cd-87ccfe381fe6
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LOZENGE
Route ORAL
Labeler Ricola Ag
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-04-03
Substance MENTHOL
Active strength 8.3 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 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 8.3 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 1424614 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54305-323-19 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC 19 in 1 BAG LOZENGE 19 5 54305-323-26 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC 26 in 1 BAG LOZENGE 26 5 54305-323-75 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC 175 in 1 BAG LOZENGE 175 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54305-323 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG] 5 Current NDC, Legacy NDC, 3 package rows 20241207_a535717d-ba55-45e9-9fc3-711b5d7dbf57.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 · 3,550 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 54305-323-19 54305032319 19 LOZENGE in 1 BAG (54305-323-19) 19 lozenge 2011-04-03 0000-00-00 No No Current 54305-323-26 54305032326 26 LOZENGE in 1 BAG (54305-323-26) 26 lozenge 2011-04-03 0000-00-00 No No Current 54305-323-75 54305032375 175 LOZENGE in 1 BAG (54305-323-75) 175 lozenge 2020-01-31 0000-00-00 No No Current