FDA.reportPublic FDA data

Zicam Cold Remedy Medicated Fruit Drops - Ultimate Orange

Manufacturer
Church & Dwight Co., Inc.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:59

Label at a glance#

ProductZicam Cold Remedy Medicated Fruit Drops - Ultimate Orange
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE
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 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 one medicated drop at onset of symptoms chew slowly and dissolve completely before swallowing repeat every 2 – 3 hours, not to exceed 5 medicated drops 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) avoid freezing and excessive heat

Label contents#

Full prescribing information#

Active ingredients (in each medicated drop)

OTC - ACTIVE INGREDIENT SECTION

Zincum aceticum 2x

Zincum gluconicum 2x

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 ® Cold Remedy was not formulated to be effective for flu or 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 one medicated drop at onset of symptoms
    • chew slowly and dissolve completely before swallowing
    • repeat every 2 – 3 hours, not to exceed 5 medicated drops 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)
  • avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, dextrose, dicalcium phosphate, disodium phosphate, FD&C Red #40, FD&C Yellow #6, flavors, malic acid, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

Questions? Comments?

OTC - QUESTIONS SECTION

Call 877-942-2626 toll free.

www.zicam.com

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORANGE FLAVOR

ZICAM ®
COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST
SIGN OF A COLD

THE

PRE-COLD ®

MEDICINE

MEDICATED
FRUIT DROPS

ULTIMATE ORANGE FLAVOR

25 DROPS • HOMEOPATHIC

ZicOrangeMFD25ctLbl.jpgZicOrangeMFD25ctLbl.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-467-252024-02-02C16284748780-1f386c64a-38d8-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Medicated Fruit Drops - Ultimate Orange
10237-467-252023-01-30C16284748780-1f386c64a-38d8-0266-e053-dadaa90a7c1aZicam ® Cold Remedy Medicated Fruit Drops - Ultimate Orange

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-467-25Zicam Cold Remedy Medicated Fruit Drops - Ultimate Orange25 in 1 BOTTLEBAR, CHEWABLE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-467ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ULTIMATE ORANGE (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) BAR, CHEWABLE [CHURCH & DWIGHT CO., INC.]2Current NDC, Legacy NDC, 1 package rows20240203_ce2bcc9c-5b88-4a58-e053-2a95a90a8fe0.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-46710237-467-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MALIC ACID817L1N4CKPIACT
PECTIN89NA02M4RXIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

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
Zicam Cold Remedy Medicated Fruit Drops - Ultimate OrangeZINC ACETATE ANHYDROUS AND ZINC GLUCONATEChurch & Dwight Co., Inc.ce2bcc9c-5b88-4a58-e053-2a95a90a8fe02024-01-02WarningsExact identifier
ndc (package): 10237-467-25
ndc (product): 10237-467
ndc11 (package): 10237046725
spl id: 1b500364-8f5f-4007-821a-d1d690a14496
spl set id: ce2bcc9c-5b88-4a58-e053-2a95a90a8fe0

Reported adverse events (FAERS/openFDA)#

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