FDA.reportPublic FDA data

Zicam ® Allergy Relief Nasal Spray

Manufacturer
Church & Dwight Co., Inc.
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:28:59

Label at a glance#

ProductZicam Allergy Relief
Active ingredientGALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SULFUR
Label structure9 sections

Indications and uses

Effective Relief of Allergy Symptoms: runny nose itchy nose watery eyes sneezing

Dosage and administration

adults and children 12 years of age and older: remove cap and safety clip (also see illustrations on side of carton) hold with thumb at bottom of bottle and nozzle between your fingers before using the first time, prime pump by depressing several times place tip of nozzle just past nasal opening (approximately 1/8") while inside nasal opening, slightly angle nozzle outward pump once into each nostril after applica...

Storage and handling

store between 15-29°C (59-84°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Galphimia glauca 12x, 30x

Histaminum hydrochloricum 12x, 30x, 200x

Luffa operculata 4x, 12x, 30x

Sulphur 12x, 30x, 200x

Purpose

OTC - PURPOSE SECTION

Upper respiratory allergy symptom relief

Uses

INDICATIONS & USAGE SECTION

  • Effective Relief of Allergy Symptoms:
    • runny nose
    • itchy nose
    • watery eyes
    • sneezing

Warnings

WARNINGS SECTION

For nasal use only.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • ear, nose, or throat sensitivity
  • susceptibility to nosebleeds
  • breathing problems such as emphysema or chronic bronchitis

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
  • the use of this container by more than one person may spread infection
  • teamporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist or are accompanied by fever

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 12 years of age and older:
    • remove cap and safety clip (also see illustrations on side of carton)
    • hold with thumb at bottom of bottle and nozzle between your fingers
    • before using the first time, prime pump by depressing several times
    • place tip of nozzle just past nasal opening (approximately 1/8")
    • while inside nasal opening, slightly angle nozzle outward
    • pump once into each nostril
    • after application, press lightly on outside of each nostril for about 5 seconds
    • wait at least 30 seconds before blowing nose
  • use once every 4 hours
  • optimal results may not be seen for 1-2 weeks. After 1-2 weeks, you may need to use only 1-2 times daily. For best results, use up to 1 week before contact with known causes of your allergies.
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 15-29°C (59-84°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, potassium chloride, potassium phosphate, purified water, sodium chloride, sodium phosphate

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®

POWERFUL

ALLERGY

RELIEF

HOMEOPATHIC

• #1•

ALLERGY BRAND*

No-Drip Liquid ®

NASAL SPRAY

Effective Relief of Allergy Symptoms:

  • Runny Nose
  • Watery Eyes
  • Itchy Nose
  • Sneezing

No Known Allergy Drug Interactions

0.50 FL OZ (15 mL)

HOMEOPATHIC

Zicam Allergy Relief Artwork.jpgZicam Allergy Relief Artwork.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-463-152024-02-02C16284748780-1f386c649-df83-0266-e053-dadaa90a7c1aZicam ® Allergy Relief Nasal Spray
10237-463-152023-01-30C16284748780-1f386c649-df83-0266-e053-dadaa90a7c1aZicam ® Allergy Relief Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-463-15Zicam Allergy Relief15 mL in 1 BOTTLE, PLASTICSPRAY155
10237-463-15Zicam Allergy Relief1 in 1 CARTONSPRAY15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-463ZICAM ALLERGY RELIEF (GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, AND SULFUR) SPRAY [CHURCH & DWIGHT CO., INC.]5Current NDC, Legacy NDC, 2 package rows20241121_ccaacde3-9920-08a2-e053-2a95a90a46e3.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-46310237-463-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
POTASSIUM CHLORIDE660YQ98I10IACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMB7862WZ632IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
SULFUR70FD1KFU70ACTIB

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 Allergy ReliefGALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, AND SULFURChurch & Dwight Co., Inc.ccaacde3-9920-08a2-e053-2a95a90a46e32024-11-19WarningsExact identifier
ndc (package): 10237-463-15
ndc (product): 10237-463
ndc11 (package): 10237046315
spl id: 27515c2e-e0b5-85c6-e063-6294a90a19a0
spl set id: ccaacde3-9920-08a2-e053-2a95a90a46e3

Reported adverse events (FAERS/openFDA)#

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