FDA.reportPublic FDA data

ZICAM

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-29 01:01:22

Label at a glance#

Productzicam cold and flu-like symptoms Echinacea plus Sambucus
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE, ECHINACEA ANGUSTIFOLIA WHOLE, SAMBUCUS NIGRA FLOWERING TOP
Label structure10 sections

Indications and uses

Reduces duration of the common cold and helps relieve nasal congestion and temporarily relieves Fever Chills Chest Congestion Hoarseness Cough Sore throat Body aches

Dosage and administration

for best results, use at the first sign of cold and flu and continue to use until symptoms completely subside. adults and children 12 years of age and older: take 1 tablet at the onset of symptoms. dissolve entire tablet in mouth. Do not chew. Do not swallow whole. repeat every 2 – 3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stom...

Storage and handling

store between 15-29°C (59-84°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each tablet)Purpose
Echinacea angustifolia 5xHelps to relieve cold and flu-like symptoms *
Sambucus nigra (elderberry) 5xHelps to relieve cold and flu-like symptoms *
Zincum aceticum 2x
Zincum gluconicum 1x 		Reduces duration of the common cold and helps relieve nasal congestion

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses

INDICATIONS & USAGE SECTION

Reduces duration of the common cold and helps relieve nasal congestion and temporarily relieves

  • Fever
  • Chills
  • Chest Congestion
  • Hoarseness
  • Cough
  • Sore throat
  • Body aches

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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

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 vomitting, consult a doctor promptly.

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms, including cough, persist, recur or are accompanied by a fever, rash or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

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 cold and flu and continue to use until symptoms completely subside.
  • adults and children 12 years of age and older:
    • take 1 tablet at the onset of symptoms.
    • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • repeat every 2 – 3 hours, not to exceed 7 tablets 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

crospovidone, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, flavors, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, silicon dioxide, sodium starch glycolate, stearic acid, sucralose.

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 - 20 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!
ZICAM ®

COLD & FLU-LIKE SYMPTOMS‡

ECHINACEA + SAMBUCUS

HELPS
WITH
6
SYMPTOMS‡

✓ COUGH
✓ HOARSENESS

✓ SORE THROAT
✓ BODY ACHES

✓ CHEST CONGESTION
✓ FEVER & CHILLS

Plus Zinc to help relieve nasal congestion

HOMEOPATHIC

20
QUICK-DISSOLVE
TABLETS

COOLING
PEPPERMINT FLAVOR

‡Claims based on traditional homeopathic practice,
not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

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
10237-47910237-479-20

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
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
CROSPOVIDONE (120 .MU.M)68401960MKIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MANNITOL3OWL53L36AIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-02-23full-release2026-06-01 02:37:53
32025-12-11monthly-update2026-06-03 17:45:00

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 cold and flu-like symptoms Echinacea plus SambucusZINC ACETATE ANHYDROUS, ZINC GLUCONATE, ECHINACEA ANGUSTIFOLIA WHOLE, AND SAMBUCUS NIGRA FLOWERING TOPChurch & Dwight Co., Inc.ff0b9ca7-a2f2-4933-99a3-ba19d59bbf132026-08-26WarningsExact identifier
ndc (package): 10237-479-20
ndc (product): 10237-479
ndc11 (package): 10237047920
spl id: 59f4b700-4e1b-6687-e063-6294a90a802a
spl set id: ff0b9ca7-a2f2-4933-99a3-ba19d59bbf13

Reported adverse events (FAERS/openFDA)#

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