FDA.reportPublic FDA data

SERYNTH FAST RELIEF NASAL

Product NDC
85248-099
11-digit product format
852480099
Labeler code
85248
Product ID
85248-099_4a4abdc0-adee-1b8a-e063-6394a90a9b56
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline HCL 0.05% FAST RELIEF NASAL
Dosage form
SPRAY
Route
NASAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
Substance
NAPHAZOLINE HCL
Active strength
.05 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SERYNTH FAST RELIEF NASAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HCL.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D
Rxcui1046610

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-099-01SERYNTH FAST RELIEF NASAL30 mL in 1 BOTTLESPRAY301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046610naphazoline HCl 0.05 % Nasal SprayPSN4a4abdc0-aded-1b8a-e063-6394a90a9b561
1046610naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4a4abdc0-aded-1b8a-e063-6394a90a9b561
1046610naphazoline HCl 0.05 % Nasal SpraySY4a4abdc0-aded-1b8a-e063-6394a90a9b561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-099-018524800990130 mL in 1 BOTTLE (85248-099-01) 30 ml2026-02-08NoNoHistorical