Home NDC 68163-704 Saline
Product NDC 68163-704
11-digit product format 681630704
Labeler code 68163
Product ID 68163-704_8cbcb020-f976-481f-9473-cda06183fc82
Type HUMAN OTC DRUG
Nonproprietary name Nasal
Dosage form SPRAY
Route NASAL
Labeler Raritan Pharmaceuiticals Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-30
Substance SODIUM CHLORIDE
Active strength 6.5 mg/mL
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 Saline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 6.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 707251 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 68163-704-15 Saline 44 mL in 1 BOTTLE SPRAY 44 6 68163-704-15 Saline 1 in 1 CARTON SPRAY 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-704 SALINE (NASAL) SPRAY [RARITAN PHARMACEUITICALS INC] 5 Current NDC, Legacy NDC, 2 package rows 20241124_4b178e4e-a10f-4b75-8140-1f7548e203ad.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 68163-704-15 68163070415 1 BOTTLE in 1 CARTON (68163-704-15) / 44 mL in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current