FDA.reportPublic FDA data

Zicam ® Allergy Relief Nasal Gel

Manufacturer
Matrixx Initiatives, Inc. | Accupac, Inc.
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:11:20

Label at a glance#

ProductZicam Allergy Relief
Active ingredientgalphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sulfur
Label structure11 sections

Indications and uses

temporarily relieves symptoms due to hay fever or other upper respiratory allergies such as: sinus pressure itchy, runny nose sneezing itchy, watery eyes nasal congestion

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#

SPL UNCLASSIFIED SECTION

Drug Facts

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

  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies such as:
    • sinus pressure
    • itchy, runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion

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
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms 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? Side Effects?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62750-001-11

ZICAM®

POWERFUL
ALLERGY
RELIEF

HOMEOPATHIC
• #1 •
ALLERGY BRAND*

No-Drip Liquid®
NASAL SPRAY

Effective Non-Drowsy Relief of:

  • Runny Nose
  • Watery Eyes
  • Itchy Nose
  • Sneezing

No Known Allergy Drug Interactions

0.50 FL OZ (15 mL)
HOMEOPATHIC

Principal Display Panel - 15 mL Bottle Carton
Principal Display Panel - 15 mL Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
galphimia glauca flowering topACTIVE INGREDIENT93PH5Q8M7E4
histamine dihydrochlorideACTIVE INGREDIENT3POA0Q644U4
luffa operculata fruitACTIVE INGREDIENTC4MO6809HU4
sulfurACTIVE INGREDIENT70FD1KFU704
galphimia glauca flowering topACTIVE MOIETY93PH5Q8M7E4
histamineACTIVE MOIETY820484N8I34
luffa operculata fruitACTIVE MOIETYC4MO6809HU4
sulfurACTIVE MOIETY70FD1KFU704
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W74
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH4
edetate disodiumINACTIVE INGREDIENT7FLD91C86K4
glycerinINACTIVE INGREDIENTPDC6A3C0OX4
potassium chlorideINACTIVE INGREDIENT660YQ98I104
potassium phosphate, unspecified formINACTIVE INGREDIENTB7862WZ6324
sodium chlorideINACTIVE INGREDIENT451W47IQ8X4
sodium phosphateINACTIVE INGREDIENTSE337SVY374
waterINACTIVE INGREDIENT059QF0KO0R4

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
62750-00162750-001-11, 62750-001-12

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
galphimia glauca flowering top93PH5Q8M7EACTIB
histamine dihydrochloride3POA0Q644UACTIB
luffa operculata fruitC4MO6809HUACTIB
sulfur70FD1KFU70ACTIB
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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 402 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION / INTRABURSALADJ PHExact identifier — unii candidate
24 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10INJECTION, SUSPENSION / INTRAVITREAL0.08 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37CONCENTRATE / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37MOUTHWASH / BUCCALNAExact identifier — unii candidate
24 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37INJECTION / ORAL10.35 mgExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAPERITONEAL0.54 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10INJECTION, SOLUTION / INTRAVENOUS330 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates

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
d704726f-b472-486c-9ac7-d89df9795bd304d551dc-23f9-414b-aac4-e92d111c867d2022-01-25WarningsExact identifier
spl id: d704726f-b472-486c-9ac7-d89df9795bd3
spl set id: 04d551dc-23f9-414b-aac4-e92d111c867d

Reported adverse events (FAERS/openFDA)#

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