FDA.reportPublic FDA data

COLD REMEDY ORAL SPRAY

Manufacturer
Dynamic Pharmaceuticals Inc.
Effective date
2010-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:39

Label at a glance#

ProductNBB
Active ingredientZINC OXIDE, ZINC GLUCONATE, SAMBUCUS NIGRA FLOWERING TOP
Label structure9 sections

Indications and uses

Reduces duration of the common cold Reduces severity of cold symptoms: Sneezing Sore Throat Stuffy Nose Coughing Congestion

Dosage and administration

For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside. Adults and children 3 years of age and older: Remove protective over-cap. Spray 4 - 5 times into mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow. Repeat every three hours until symptoms are gone. To avoid minor stomach upset, do n...

Storage and handling

Store at room temperature 15°C-29°C (59°F-84°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Zincum Oxydatum 1XReduces duration
Zincum Gluconicum 1Xand severity of the
Sambucus nigra 1Xcommon cold

Uses

INDICATIONS & USAGE SECTION

  • Reduces duration of the common cold
  • Reduces severity of cold symptoms:
    • Sneezing
    • Sore Throat
    • Stuffy Nose
    • Coughing
    • Congestion

Warnings

WARNINGS SECTION

For oral use only, not for use in nasal pathways.

When using this product

  • Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.
  • Stop use and ask doctor if
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

CVS Cold Remedy Oral Spray was formulated to shorten the duration of the common cold and may not be effective for flu or allergies.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or if accompanied by fever.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
  • Adults and children 3 years of age and older:
    • Remove protective over-cap.
    • Spray 4 - 5 times into mouth at the onset of symptoms.
    • Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
    • Repeat every three hours 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 3 years of age:
    • Consult a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Peppermint Flavor, Potassium Sorbate, Purified Water, Sucralose

STORAGE AND HANDLING SECTION

Store at room temperature 15°C-29°C (59°F-84°F)

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS®
pharmacy

Compare
& save

NEW!

COLD
REMEDY
ORAL SPRAY

ZINCUM OXYDATUM
ZINCUM GLUCONICUM
SAMBUCUS NIGRA
 

  • Shortens the
    duration &
    severity of the
    common cold
  • No metallic
    aftertaste

CVS PHARMACIST
RECOMMENDED

Homeopathic

Natural
mint flavor

1 FL OZ/30 mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64762-862-302019-10-21C16284748780-1956f9ecf-dcd1-621f-e053-dbdaa90a74adCOLD REMEDY ORAL SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64762-862-30NBB1 in 1 CARTONSPRAY, METERED11
64762-862-30NBB30 mL in 1 BOTTLE, PUMPSPRAY, METERED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64762-862NBB (ZINC OXIDE, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP) SPRAY, METERED [DYNAMIC PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20100601_6dbfe4b8-db7a-489b-ae51-21ceb9d4aa50.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18U1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18U1
ZINCACTIVE MOIETYJ41CSQ7QDS1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64762-86264762-862-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB

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
c4b19477-d349-49ae-9cad-167ab21899b16dbfe4b8-db7a-489b-ae51-21ceb9d4aa502010-05-24WarningsExact identifier
spl id: c4b19477-d349-49ae-9cad-167ab21899b1
spl set id: 6dbfe4b8-db7a-489b-ae51-21ceb9d4aa50

Reported adverse events (FAERS/openFDA)#

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