FDA.reportPublic FDA data

TopCare Sore Throat Spray Sugar Free

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:43:14

Label at a glance#

ProductTopcare Sore Throat Menthol Flavor
Active ingredientPHENOL
Label structure9 sections

Indications and uses

For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat.

Dosage and administration

Adults and children 12 year of age and older: Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out. Use every 2 hours or as directed by a doctor or dentist Children under 12 years of age: Should be supervised in use of this product. Children under 6 years of age : Ask a doctor or dentist

Storage and handling

store at room temperature Check expiration date before using.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

WARNINGS SECTION

Sore throat warning:Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 year of age unless directed by doctor.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or accidental,get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 year of age and older:

Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out.

Use every 2 hours or as directed by a doctor or dentist

  • Children under 12 years of age:Should be supervised in use of this product.
  • Children under 6 years of age: Ask a doctor or dentist

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • Check expiration date before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®health ™

NDC# 36800-606-06

COMPARE TO THE CHLORASEPTIC® ACTIVE INGREDIENT*

SUGAR FREE

Sore Throat Spray

PHENOL / ORAL ANESTHETIC

  • Works on Contact
  • Relieves Sore Throat Pain
  • Fast Acting

ASPIRIN FREE

ALCOHOL FREE

MENTHOL FLAVOR

OUR PHARMACIST RECOMMEND

6 FL OZ (177 mL)

QUALITY GUARANTEED

*This product is not manufactured or distributed by Prestige Brands Co., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR TORN.

DISTRIBUTED BY TOPCO ASSOCIATESLLC,

ELK GROVE VILLAGE, IL 6007

TOPCO RARA1217

QUESTIONS? 1-888-423-0139

topcare@topco.comwww.tocarebrand.com

TopCare Sore Throat Spray Menthol Flavor
TopCare Sore Throat Spray Menthol Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198776phenol 1.4 % Mucosal SprayPSN6
198776phenol 14 MG/ML Mucosal SpraySCD6
198776phenol 1.4 % Mucosal SpraySY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800145436GTIN-13: 0036800145436
EAN-13: 0036800145436
GTIN-12: 036800145436
UPC-A: 036800145436
GTIN storage (14 digits): 00036800145436		703MEN06TOP artwork.png.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-606-06Topcare Sore ThroatMenthol Flavor177 mL in 1 BOTTLE, SPRAYSPRAY1776

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-60636800-606-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C GREEN NO. 33P3ONR6O1SIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
PHENOL339NCG44TVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-06full-release2026-06-01 00:34:36

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
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
ndc (package): 36800-606-06
ndc (product): 36800-606
ndc11 (package): 36800060606
spl id: 433b6818-d6bd-3e2a-e063-6394a90aaec4
spl set id: fb1f2c11-2508-4985-bae5-7d547bd6aa23

Reported adverse events (FAERS/openFDA)#

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