FDA.reportPublic FDA data

Topcare Sore Throat

Product NDC
36800-606
11-digit product format
368000606
Labeler code
36800
Product ID
36800-606_433b6818-d6bd-3e2a-e063-6394a90aaec4
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-06
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings 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, do not exceed recommended dosage. Stop use and ask a doctor or dentist if 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, ask a doctor before use. Keep out of reach of children. In case of overdose or accidental, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Sore Throat
Brand name suffix
Menthol Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL1.4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii339NCG44TV
Rxcui198776

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-606TOPCARE SORE THROAT MENTHOL FLAVOR (PHENOL) SPRAY [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 1 package rows20241107_fb1f2c11-2508-4985-bae5-7d547bd6aa23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSNfb1f2c11-2508-4985-bae5-7d547bd6aa236
198776phenol 14 MG/ML Mucosal SpraySCDfb1f2c11-2508-4985-bae5-7d547bd6aa236
198776phenol 1.4 % Mucosal SpraySYfb1f2c11-2508-4985-bae5-7d547bd6aa236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-606-0636800060606177 mL in 1 BOTTLE, SPRAY (36800-606-06) 177 ml2019-03-060000-00-00NoNoCurrent