FDA.reportPublic FDA data

Vicks

Manufacturer
Procter & Gamble Manufacturing GmbH,
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:54:41

Label at a glance#

ProductVicks Sinex SEVERE ORIGINAL ULTRA FINE MIST
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies sinus congestion and pressure

Dosage and administration

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. adults & children 6 yrs. & older (with adult supervision) 2 or 3 sprays in each nostril, not more often th...

Storage and handling

do not exceed 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCl 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
  • 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 enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms 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.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

adults & children 6 yrs. & older (with adult supervision)2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours.
children 2 to under 6 yrs.ask a doctor
children under 2 yrs.do not use

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, purified water, sodium citrate, sorbitol

Questions?

OTC - QUESTIONS SECTION

1-800-873-8276

SPL UNCLASSIFIED SECTION

Only selected information is listed on the bottle label. Keep this carton for future reference.

TAMPER EVIDENT: Carton sealed for your protection.

SPL UNCLASSIFIED SECTION

MADE IN GERMANY

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

Sinex™

SEVERE

Oxymetazoline HCl Nasal Decongestant

ORIGINAL

Ultra Fine Mist

  • Fast Sinus Congestion & Pressure Relief
  • Powerful Vicks Vapors

12
HOUR

½ FL OZ
(15 ml)

171171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN9
1001066Vicks Sinex 12Hr Decongestant 0.05 % Nasal SprayPSN9
1001066oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]SBD9
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD9
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY9
1001066Sinex Long-Acting 0.5 MG/ML Nasal SpraySY9
1001066Vicks Sinex 12-HR Decongestant 0.05 % Nasal SpraySY9
1001066Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal SpraySY9
1001066Vicks Sinex Long-Acting 0.05 % Nasal SpraySY9

DailyMed Pharmacologic Classes#

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

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
64336-171-01Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST15 mL in 1 BOTTLE, PUMPSPRAY159
64336-171-01Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST1 in 1 CARTONSPRAY19
64336-171-02Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST15 mL in 1 BOTTLE, PUMPSPRAY159
64336-171-02Vicks Sinex SEVEREORIGINAL ULTRA FINE MIST2 in 1 CARTONSPRAY29

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
64336-17164336-171-01, 64336-171-02

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-03monthly-update2026-06-03 17:45:18

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
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
ndc (package): 64336-171-02
ndc (package): 64336-171-01
ndc (product): 64336-171
ndc11 (package): 64336017101
ndc11 (package): 64336017102
spl id: 500f4e9a-1229-dc5d-e063-6294a90afe5c
spl set id: cfd43b8f-8064-6b88-e053-2a95a90a329e

Reported adverse events (FAERS/openFDA)#

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