FDA.reportPublic FDA data

Zicam

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-29 01:01:22

Label at a glance#

ProductZicam Ultra Cold Remedy Rapidmelts
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE
Label structure11 sections

Indications and uses

Reduces duration of the common cold and helps relieve nasal congestion Zicam® ULTRA 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: 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 n...

Storage and handling

store between 15-29°C (59-84°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

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

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

Warnings

WARNINGS SECTION

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

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:
    • 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, flavor, magnesium stearate, mannitol, monoammonium glycyrrhizinate, 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 - 18 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHORTENS COLDS

SUGAR-FREE
DYE-FREE

RAPIDMELTS ®

Orange Cream
Flavor

18
Quick Dissolve
TABLETS

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 18 Tablet Bottle Carton
PRINCIPAL DISPLAY PANEL - 18 Tablet 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
10237-47610237-476-18

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
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CROSPOVIDONE (120 .MU.M)68401960MKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-08-29full-release2026-06-01 02:27:51

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 Ultra Cold Remedy RapidmeltsZINC ACETATE ANHYDROUS AND ZINC GLUCONATEChurch & Dwight Co., Inc.b0fa5e55-ce51-4f6e-a216-08b526b7f8782026-08-26WarningsExact identifier
ndc (package): 10237-476-18
ndc (product): 10237-476
ndc11 (package): 10237047618
spl id: 59f513fc-e9e5-f1a9-e063-6294a90a335b
spl set id: b0fa5e55-ce51-4f6e-a216-08b526b7f878

Reported adverse events (FAERS/openFDA)#

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