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QUALITY CHOICE

Quality Choice Sore Throat Spray

Approved
Approval ID

c95ee086-f384-475d-ad0c-75518cb9d2fe

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

CHAIN DRUG MARKETING ASSOCIATION

DUNS: 011920774

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phenol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83324-275
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Phenol
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (5)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
PHENOLActive
Quantity: 1.4 g in 100 mL
Code: 339NCG44TV
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/10/2025

Package Label

Quality Choice Sore Throat Cherry Flavor 6 Fl OZ

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/10/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/10/2025

Active ingredient

Phenol 1.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/10/2025

Purpose

Oral pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 6/10/2025

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 years of age unless directed by a doctor.

When using this product,

do not exceed recommended dosage.

Stop use and ask a dentist or doctor 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.

If more than used for minor mouth or throat pain is accidentally swallowed **,**get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/10/2025

Directions

*Adults and children 12 years 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 as directed by a doctor or dentist *Children 6 years to under 12 years of age: should be supervised in the use of this product *Children under 6 years of age: Consult a doctor or dentist

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/10/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/10/2025

Inactive ingredients

FD&C Red No. 40, flavor, glycerin, purified water, sucralose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/10/2025

Questions or comments?

1-866-467-2748

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QUALITY CHOICE - FDA Drug Approval Details