Home NDC 85471-001 Shusher Care
Product NDC 85471-001
11-digit product format 854710001
Labeler code 85471
Product ID 85471-001_31b9d1a0-9301-beab-e063-6294a90a24ef
Type HUMAN OTC DRUG
Nonproprietary name ISOTONIC SODIUM CHLORIDE
Dosage form LIQUID
Route RESPIRATORY (INHALATION)
Labeler pNeo LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-04-01
Substance ISOTONIC SODIUM CHLORIDE SOLUTION
Active strength .9 g/100mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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 Shusher Care
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTONIC SODIUM CHLORIDE SOLUTION .9 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VR5Y7PDT5W Internal UNII 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 85471-001-01 Shusher Care 20 in 1 PACKAGE LIQUID 20 1 85471-001-01 Shusher Care 5 mL in 1 BOTTLE LIQUID 5 1 85471-001-02 Shusher Care 50 in 1 PACKAGE LIQUID 50 1 85471-001-02 Shusher Care 5 mL in 1 BOTTLE LIQUID 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85471-001 SHUSHER CARE (ISOTONIC SODIUM CHLORIDE) LIQUID [PNEO LLC] 1 Current NDC, 4 package rows 20250403_1bac18ca-5446-4ca7-9e2f-42d701c8cf46.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85471-001-01 85471000101 20 BOTTLE in 1 PACKAGE (85471-001-01) / 5 mL in 1 BOTTLE 20 bottle 2025-04-01 No No Current 85471-001-02 85471000102 50 BOTTLE in 1 PACKAGE (85471-001-02) / 5 mL in 1 BOTTLE 50 bottle 2025-04-01 No No Current