FDA.reportPublic FDA data

Zicam

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-29 01:01:16

Label at a glance#

ProductZicam Cold Remedy Rapidmelts Elderberry Citrus
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE, SAMBUCUS NIGRA FLOWERING TOP
Label structure9 sections

Indications and uses

reduces duration of the common cold and helps relieve nasal congestion Zicam ® Cold Remedy was not formulated to be effective for flu and 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#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Zincum aceticum 2x

Zincum gluconicum 1x

Sambucus nigra (elderberry) 5x

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Zincum aceticum 2x

Zincum gluconicum 1x 		Reduces duration of the common cold and helps relieve nasal congestion
Sambucus nigra (elderberry) 5xHelps relieve cold symptoms *

* 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

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms 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

ascorbic acid, crospovidone, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose

Questions? Comments? Side Effects?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

www.zicam.com

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

plus ELDERBERRY

ZICAM®

COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST

SIGN OF A COLD

THE

PRE-COLD®

MEDICINE

ZICAM®

COLD REMEDY

SHORTENS COLDS

RAPIDMELTS®

Citrus Flavor

SHORTENS COLDS • TWO FORMS OF ZINC

plus ELDERBERRY

RAPIDMELTS®

Citrus Flavor

25

Quick Dissolve

TABLETS

HOMEOPATHIC

7379 ZicRMEldrbrryCtrs25ctCrtn-FNL.jpg7379 ZicRMEldrbrryCtrs25ctCrtn-FNL.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-461-252024-02-02C16284748780-1f386c649-e180-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Rapidmelts® Elderberry Citrus
10237-461-252024-02-02C16284748780-1f386c649-e180-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Rapidmelts® Elderberry Citrus
10237-461-252023-01-30C16284748780-1f386c649-e180-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Rapidmelts® Elderberry Citrus
10237-461-252023-01-30C16284748780-1f386c649-e180-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Rapidmelts® Elderberry Citrus

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-46110237-461-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
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
22024-01-02full-release2026-06-01 02:25:58

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 Remedy Rapidmelts Elderberry CitrusZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOPChurch & Dwight Co., Inc.bbf1c8b7-56f8-ee7f-e053-2995a90a7b272026-08-26WarningsExact identifier
ndc (package): 10237-461-25
ndc (product): 10237-461
ndc11 (package): 10237046125
spl id: 59f4705b-40cf-64a0-e063-6394a90a78af
spl set id: bbf1c8b7-56f8-ee7f-e053-2995a90a7b27

Reported adverse events (FAERS/openFDA)#

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