Home NDC 50804-593 Cough Drops
Product NDC 50804-593
11-digit product format 508040593
Labeler code 50804
Product ID 50804-593_23e5789b-ba1e-fcbf-e063-6294a90a5807
Type HUMAN OTC DRUG
Nonproprietary name Simply Honey Lemon
Dosage form PASTILLE
Route ORAL
Labeler Perrigo Direct Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-12
Substance MENTHOL
Active strength 7.5 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 7.5 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 1250189 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 50804-593-01 Cough Drops 30 in 1 BAG PASTILLE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-593 COUGH DROPS (SIMPLY HONEY LEMON) PASTILLE [PERRIGO DIRECT INC.] 2 Current NDC, 1 package rows 20241009_fb898616-d604-b4c3-e053-6294a90a23bf.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 Sample Exclude flag Status 50804-593-01 50804059301 30 PASTILLE in 1 BAG (50804-593-01) 30 pastille 2023-05-12 No No Current