Home NDC 52183-227 Ludens
Product NDC 52183-227
11-digit product format 521830227
Labeler code 52183
Product ID 52183-227_596bafe3-fc62-46eb-e063-6294a90a9431
Type HUMAN OTC DRUG
Nonproprietary name pectin and menthol
Dosage form LOZENGE
Route ORAL
Labeler Prestige Brands Holdings, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-15
Marketing end 2027-03-31
Substance PECTIN; MENTHOL
Active strength 2.8; 2.5 mg/1; mg/1
NDC exclude flag No
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 Ludens
Brand name suffix Dual Relief Active Ingredients# Ingredient, Strength table Ingredient Strength PECTIN 2.8 mg/1 MENTHOL 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89NA02M4RX Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2056063 Internal RxNorm lookup 2056069 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52183-227-25 LudensDual Relief 25 in 1 BAG LOZENGE 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52183-227 LUDENS DUAL RELIEF (PECTIN AND MENTHOL) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241113_d0213cb3-ec8e-40cc-82c9-694032f0490f.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 27 of 40 · 786 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 52183-227-25 52183022725 25 LOZENGE in 1 BAG (52183-227-25) 25 lozenge 2018-06-15 2027-03-31 No No Current