Home NDC 51316-199 Sore Throat
Product NDC 51316-199
11-digit product format 513160199
Labeler code 51316
Product ID 51316-199_aedc6546-b604-468c-8a1b-f89e871f9d31
Type HUMAN OTC DRUG
Nonproprietary name Phenol Glycerin
Dosage form SPRAY
Route ORAL
Labeler CVS PHARMACY, INC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-25
Substance PHENOL; GLYCERIN
Active strength 1.5; 33 mg/100mL; mg/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOL 1.5 mg/100mL GLYCERIN 33 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 339NCG44TV Internal UNII lookup PDC6A3C0OX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1101852 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 51316-199-04 Sore Throat 118 mL in 1 BOTTLE, SPRAY SPRAY 118 2
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 9 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 Sample Exclude flag Status 51316-199-04 51316019904 118 mL in 1 BOTTLE, SPRAY (51316-199-04) 118 ml 2025-12-25 No No Current