FDA.reportPublic FDA data

Zicam Cold Remedy Oral Mist

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:44:53

Label at a glance#

ProductZicam Cold Remedy Oral Mist
Active ingredientZINC ACETATE, ZINC GLUCONATE
Label structure11 sections

Indications and uses

reduces duration of the common cold and helps relieve nasal congestion soothes sore throats and coughs ‡ Zicam ® Cold Remedy was not formulated to be effective for flu or allergies.

Dosage and administration

for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow. repeat every 2 – 3 hours, not to exceed 7 doses in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take o...

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

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

OTC - PURPOSE SECTION

Reduces duration of the common cold and helps relieve nasal congestion

Uses

INDICATIONS & USAGE SECTION

  • reduces duration of the common cold and helps relieve nasal congestion
  • soothes sore throats and coughs ‡

Zicam ®Cold Remedy was not formulated to be effective for flu or allergies.

Warnings

WARNINGS SECTION

For oral use only

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - ASK DOCTOR SECTION

If you are allergic or sensitive to zinc,consult a doctor before using.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist or are accompanied by a fever or new symptoms occur.

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.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for best results, use at the first sign of a cold and continue to use until symptoms completely subside
  • adults and children 12 years of age and older:
    • spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
    • repeat every 2 – 3 hours, not to exceed 7 doses in 24 hours. Take until symptoms are gone.
    • to avoid minor stomach upset, do not take on an empty stomach
    • do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
  • children under 12 years of age: ask a doctor before use

Other information

STORAGE AND HANDLING SECTION

  • store between 15-29°C (59-84°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, glycerin, flavors, PEG-40 hydrogenated castor oil, purified water, sucralose, xylitol

Questions? Comments?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CHURCH & DWIGHT CO., INC.
EWING, NJ 08628

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZICAM ®
COLD REMEDY

SHORTENS COLDS

+ SOOTHES SORE THROATS
AND COUGHS ‡

TAKE AT THE FIRST
SIGN OF A COLD

THE
PRE-COLD ®
MEDICINE

SEE
WHAT'S
INSIDE!

SHORTENS COLDS

ORAL MIST™

GREAT TASTING

Arctic Mint Flavor

1.0 FL OZ
(30 mL)

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

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
10237-47510237-475-01

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
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
ZINC ACETATEFM5526K07AACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB

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
452358ed-219b-094a-e063-6394a90a2f5e6ba965e8-e665-4336-9d43-547d3d1fb8052025-12-04WarningsExact identifier
spl id: 452358ed-219b-094a-e063-6394a90a2f5e
spl set id: 6ba965e8-e665-4336-9d43-547d3d1fb805

Reported adverse events (FAERS/openFDA)#

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