0.9% Sodium Chloride Saline Solution

Product NDC
84763-012
11-digit product format
847630012
Labeler code
84763
Product ID
84763-012_546af257-dbd2-11fc-e063-6394a90a8e0a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Chloride
Dosage form
LIQUID
Route
NASAL
Labeler
Yunqi Cosmetics (Shenzhen) Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-17
Substance
SODIUM CHLORIDE
Active strength
.009 g/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
0.9% Sodium Chloride Saline Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE.009 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313000Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
546af257-dbd1-11fc-e063-6394a90a8e0aAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
ndc (product): 84763-012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84763-012-018476300120121 BOTTLE in 1 BOX (84763-012-01) / 5 mL in 1 BOTTLE21 bottle2026-06-17NoNoCurrent