MedPath

Sore Throat Cherry

Drug Facts

Approved
Approval ID

d1e80892-a9ef-4ff5-9577-1e89b71b02b5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

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 Code0904-6305
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Phenol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 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: 1.5 g in 100 mL
Code: 339NCG44TV
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Principal Display Pane

COMPARE TO the active ingredient in CHLORASEPTIC ®*

NDC 0904-6305-21

MAJOR ®

Cherry flavor

Sore Throat Spray

Relieves Sore Throat Pain

New Sprayer

SUGAR- FREE

ASPIRIN-FREE

GLUTEN-FREE

Cherry Flavor

6 FL OZ (177 mL)

Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing

Distributed By

MAJOR ®PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ®.

![Sore Throat Spray Cherry](/dailymed/image.cfm?name=sore-throat-spray- cherry-1.jpg&id=898642)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Active Ingredient

Phenol 1.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Purpose

Oral Anesthetic/Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

Warnings

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/19/2025

When using this product

do not exceed recommended dosage.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/19/2025

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/19/2025

If pregnant or breast-feeding

ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2025

Drug Facts (continued)

Keep out of the reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

  • Apply to the 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. ***Adults and children 6 years of age and older:**For each application, spray 5 times. *Children under 12 years of ageshould be supervised in the use of this product. *Children under 3 years of age: Ask a doctor or dentist.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/19/2025

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive Ingredients

FD&C Red # 40, flavor, glycerin, purified water, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/19/2025

Questions or comments?

1-800-616-2471

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Sore Throat Cherry - FDA Drug Approval Details