Home NDC 49580-0376 Sore Throat
Product NDC 49580-0376
11-digit product format 495800376
Labeler code 49580
Product ID 49580-0376_b0aae576-6544-4bc5-af3c-d7edb7c7a35c
Type HUMAN OTC DRUG
Nonproprietary name Phenol
Dosage form SPRAY
Route ORAL
Labeler P & L Development, LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-11-30
Substance PHENOL
Active strength 1.4 g/100mL
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 Sore Throat
Brand name suffix ReadyInCase
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOL 1.4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 339NCG44TV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198776 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 49580-0376-6 Sore ThroatReadyInCase 177 mL in 1 BOTTLE, SPRAY SPRAY 177 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0376 SORE THROAT READYINCASE (PHENOL) SPRAY [P & L DEVELOPMENT, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20241115_2fb3d17e-8ca3-4edb-8b82-4b484f42616e.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 14 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 49580-0376-6 49580037606 177 mL in 1 BOTTLE, SPRAY (49580-0376-6) 177 ml 2014-11-30 0000-00-00 No No Current