Home NDC 69396-116 Saline Ampoules
Product NDC 69396-116
11-digit product format 693960116
Labeler code 69396
Product ID 69396-116_410d90c1-c459-8577-e063-6394a90a8254
Type HUMAN OTC DRUG
Nonproprietary name Sodium Chloride 0.9%
Dosage form SPRAY
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-07-28
Substance SODIUM CHLORIDE
Active strength 9 mg/mL
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 Saline Ampoules
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 9 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 351179 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 69396-116-05 Saline Ampoules 5 mL in 1 VIAL SPRAY 5 3 69396-116-05 Saline Ampoules 60 in 1 CARTON SPRAY 60 3
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 1 of 1 · 1 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 69396-116-05 69396011605 60 VIAL in 1 CARTON (69396-116-05) / 5 mL in 1 VIAL 60 vial 2022-11-22 No No Current