Home NDC 68163-703 SORE THROAT
Product NDC 68163-703
11-digit product format 681630703
Labeler code 68163
Product ID 68163-703_4da4d5bf-258d-44fa-b82a-3d0292622354
Type HUMAN OTC DRUG
Nonproprietary name Phenol
Dosage form SPRAY
Route ORAL
Labeler Raritan Pharmaceuticals Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-29
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
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68163-703-06 SORE THROAT 177 mL in 1 BOTTLE, SPRAY SPRAY 177 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-703 SORE THROAT (PHENOL) SPRAY [RARITAN PHARMACEUTICALS INC] 5 Current NDC, Legacy NDC, 1 package rows 20241124_43ce374a-824c-4034-bf04-c351b4d8015b.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 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 Marketing end Sample Exclude flag Status 68163-703-06 68163070306 177 mL in 1 BOTTLE, SPRAY (68163-703-06) 177 ml 2020-07-29 0000-00-00 No No Current