Topcare Sore Throat Menthol Flavor

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Topcare Sore Throat Menthol Flavor
Generic name: PHENOL
Manufacturer: TOPCO ASSOCIATES LLC
Product type: HUMAN OTC DRUG
SPL set ID: fb1f2c11-2508-4985-bae5-7d547bd6aa23
SPL ID: 433b6818-d6bd-3e2a-e063-6394a90aaec4
Version: 6
Effective date: 2025-11-10
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:19

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Topcare Sore Throat Menthol Flavor	openfda.brand_name
generic name		PHENOL	openfda.generic_name
manufacturer name		TOPCO ASSOCIATES LLC	openfda.manufacturer_name
ndc	package	36800-606-06	openfda.package_ndc
ndc	product	36800-606	openfda.product_ndc
ndc11	package	36800060606	derived:openfda.package_ndc
rxcui		198776	openfda.rxcui
spl id		433b6818-d6bd-3e2a-e063-6394a90aaec4	id
spl set id		fb1f2c11-2508-4985-bae5-7d547bd6aa23	set_id
unii		339NCG44TV	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

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).

Reported adverse events (FAERS/openFDA)#

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