FDA.reportPublic FDA data

ZICAM ® Allergy Relief Gel Swabs

Manufacturer
Matrixx Initiatives, Inc. | Unicep
Effective date
2018-11-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:47:27

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: open tube (also see illustrations on side of carton): hold tube between thumb and forefinger at the blue band with the other hand hold at base of handle and snap open tube pull out swab apply medication just inside first nostril. Remove swab and press lightly on the outside of first nostril for about 5 seconds. Re-dip swab in tube. Apply medication to second nostril. ...

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
  • the use of individual swabs 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:
    • open tube (also see illustrations on side of carton):
      • hold tube between thumb and forefinger at the blue band
      • with the other hand hold at base of handle and snap open tube
      • pull out swab
    • apply medication just inside first nostril. Remove swab and press lightly on the outside of first nostril for about 5 seconds. Re-dip swab in tube. Apply medication to second nostril. Remove swab and press lightly on the outside of the second nostril for about 5 seconds. Do not insert swab more than 1/4″ past nasal opening.
    • discard swab after use
    • wait at least 30 seconds before blowing nose
    • use 1 tube 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, menthol, potassium chloride, potassium phosphate, purified water, sodium chloride, sodium phosphate

Questions? Comments? Side Effects?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free
www.zicam.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62750-004-15

ZICAM®

GENTLE
ALLERGY
RELIEF

THE ONLY
ALLERGY RELIEF
NASAL SWAB

NASAL SWABS
with Cooling Menthol

Effective Non-Drowsy Relief of:

• Nasal Congestion    • Itchy Eyes
• Itchy, Runny Nose   • Sneezing

No Known Allergy Drug Interactions

15 MEDICATED SWABS
HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton
PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62750-004-152022-01-30C16284748780-1d6a99b39-4f77-a426-e053-dadaa90af4c2ZICAM ® Allergy Relief Gel Swabs
62750-004-152022-01-28C16284748780-1d6a99b39-4f77-a426-e053-dadaa90af4c2ZICAM ® Allergy Relief Gel Swabs

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
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP4
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A4
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 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62750-00462750-004-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
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 8 · 427 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / TOPICAL0.23 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVASCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, SOLUTION / INTRAMUSCULAR0.14 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPSOLUTION / TOPICAL0.6 %w/vExact identifier — unii candidate
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SUSPENSION / ORAL40 mgExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 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
ce313a51-7c9b-4ac3-a7ef-59b8f2a9e736c55e0ea1-bb67-4595-8938-d62b144efa592022-01-28WarningsExact identifier
spl set id: c55e0ea1-bb67-4595-8938-d62b144efa59

Reported adverse events (FAERS/openFDA)#

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