FDA.reportPublic FDA data

Rugby

Manufacturer
RUGBY LABORATORIES
Effective date
2025-10-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:40:00

Label at a glance#

ProductRugby Cherry Flavor
Active ingredientPHENOL
Label structure10 sections

Indications and uses

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

Dosage and administration

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 under 12 years of age : should be supervised in the 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 relief 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 years of age unless directed by a doctor.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a dentist or doctor 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 poisoning,get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 under 12 years of age: should be supervised in the 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 Red No. 40, flavor, glycerin, purified water, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®

NDC# 0536-1228-58

Rugby ®

SUGAR-FREE

CHERRY Phenaseptic

Oral Anesthetic/Analgesic

For Relief of Minor

Sore Throat Pain

Phenol 1.4%

Naturally and Artificially Flavored

Aspirin Free

Sugar Free

6 FL OZ (177 mL)

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

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

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Sugar Free Cherry Flavor Phenaseptic Phenol 1.4%
Rugby Sugar Free Cherry Flavor Phenaseptic Phenol 1.4%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198776phenol 1.4 % Mucosal SprayPSN7
198776phenol 14 MG/ML Mucosal SpraySCD7
198776phenol 1.4 % Mucosal SpraySY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130305361228583GTIN-13: 0305361228583
EAN-13: 0305361228583
GTIN-12: 305361228583
UPC-A: 305361228583
GTIN storage (14 digits): 00305361228583		sore-throat-spray-cherry-liquid-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1228-58RugbyCherry Flavor177 mL in 1 BOTTLE, SPRAYSPRAY1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1228-58ML - Milliliter0536-1228348cf1c5-f6b2-4c23-9c8b-b42241b3e75512019-06-19

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12280536-1228-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
PHENOL339NCG44TVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-31full-release2026-06-01 00:32:49

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
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
ndc (package): 0536-1228-58
ndc (product): 0536-1228
ndc11 (package): 00536122858
spl id: 41f51af3-4766-7a5a-e063-6394a90aa437
spl set id: 3d668c78-8130-45d4-bcb7-dddcb2fbe7a3

Reported adverse events (FAERS/openFDA)#

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