FDA.reportPublic FDA data

Zicam ® Extreme Congestion Relief Nasal Spray

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:22:22

Label at a glance#

ProductZicam Extreme Congestion Relief
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves nasal congestion due to: the common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure helps clear nasal passages shrinks swollen membranes

Dosage and administration

adults and children 6 to under 12 years of age (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 any 24-hour period. children under 6 years of age: ask a doctor To use pump: to open, hold the actuator to squeeze and turn cap hold with thumb at bottom of bottle and nozzle between fingers before using the first time, prime pump by depressing se...

Label contents#

Full prescribing information#

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:
    • the common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages
  • shrinks swollen membranes

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

  • 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.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
  • 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 or 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 use pump:

  • to open, hold the actuator to squeeze and turn cap
  • hold with thumb at bottom of bottle and nozzle between fingers
  • before using the first time, prime pump by depressing several times
  • place tip of nozzle just past nasal opening (approximately 1/8")
  • pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
  • wipe nozzle clean after use
  • to close, turn cap until it 'clicks'

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, monosodium phosphate, purified water

Questions? Comments?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

www.zicam.com

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZICAM ®

EXTREME
CONGESTION
RELIEF

OXYMETAZOLINE HCl 0.05%
NASAL DECONGESTANT

12
HOUR
RELIEF

COLDS*ALLERGIES

Fast, Powerful
Congestion
Relief

No-Drip Liquid ®
NASAL SPRAY

Soothing
Aloe Vera

0.50 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
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN4
1001084Zicam Congestion Relief 0.05 % Nasal SprayPSN4
1001084oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Zicam Sinus Relief]SBD4
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY4
1001084Zicam Extreme Congestion Relief 0.05 % Nasal SpraySY4
1001084Zicam Sinus Relief 0.05 % Nasal SpraySY4
1001084Zicam Sinus Relief 0.5 MG/ML Nasal SpraySY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-464-152023-03-09C16284748780-1f386c64a-1e1c-0266-e053-dadaa90a7c1aZicam ® Extreme Congestion Relief Nasal Spray
10237-464-152023-01-30C16284748780-1f386c64a-1e1c-0266-e053-dadaa90a7c1aZicam ® Extreme Congestion Relief Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-464-15Zicam Extreme Congestion Relief1 in 1 CARTONSPRAY14
10237-464-15Zicam Extreme Congestion Relief15 mL in 1 BOTTLE, PLASTICSPRAY154

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-46410237-464-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
WATER059QF0KO0RIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

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
Zicam Extreme Congestion ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.ccada339-656c-a461-e053-2a95a90a34792025-12-31WarningsExact identifier
ndc (package): 10237-464-15
ndc (product): 10237-464
ndc11 (package): 10237046415
spl id: 45a8542f-37c2-3200-e063-6394a90ac1fe
spl set id: ccada339-656c-a461-e053-2a95a90a3479

Reported adverse events (FAERS/openFDA)#

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