FDA.reportPublic FDA data

Dristan

Manufacturer
Foundation Consumer Brands
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:10

Label at a glance#

ProductDristan 12 hr
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves nasal congestion due to a cold, hay fever or other upper respiratory allergies shrinks swollen membranes temporarily restores freer breathing through the nose temporarily relieves sinus congestion and pressure

Dosage and administration

adults and children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.

Storage and handling

store at 20-25°C (68-77°F) container is filled to proper level for correct spray action retain carton for full labeling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to a cold, hay fever or other upper respiratory allergies
  • shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • do not use for more than 3 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen
  • may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
  • the use of this container by more than one person may spread infection

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • container is filled to proper level for correct spray action
  • retain carton for full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-594-0710weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dristan ®
12
HOUR
NASAL
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Fast Acting Relief
Sinus & Nasal
Congestion

Relieves:

  • Sinus Congestion & Pressure
  • Nasal Congestion due to
    Colds & Allergies
  • Swelling of Nasal Passages

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000996Dristan 12-Hour 0.05 % Nasal SprayPSN3
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3
1000996oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Dristan 12-Hour Nasal Spray]SBD3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3
1000996Dristan 12-Hour 0.05 % Nasal SpraySY3
1000996Dristan 12-Hour 0.5 MG/ML Nasal SpraySY3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1281027dristan-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-400-05Dristan12 hr15 mL in 1 BOTTLE, SPRAYSPRAY153
80070-400-05Dristan12 hr1 in 1 CARTONSPRAY13
80070-400-15Dristan12 hr45 mL in 1 CARTONSPRAY453

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80070-40080070-400-05, 80070-400-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PHOSPHORIC ACIDE4GA8884NNIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE DISODIUM7FLD91C86KIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-07full-release2026-06-01 00:35:36

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
Dristan 12 hrOXYMETAZOLINE HYDROCHLORIDEFoundation Consumer Brands522876fe-a412-4ca8-bfad-a313e3cbc1af2025-10-24WarningsExact identifier
ndc (package): 80070-400-05
ndc (package): 80070-400-15
ndc (product): 80070-400
ndc11 (package): 80070040015
ndc11 (package): 80070040005
spl id: 41e7cd3f-510d-0976-e063-6394a90abe9e
spl set id: 522876fe-a412-4ca8-bfad-a313e3cbc1af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.