FDA.reportPublic FDA data

Sore Throat

Manufacturer
CVS PHARMACY, INC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:48:26

Label at a glance#

ProductSore Throat
Active ingredientPHENOL, GLYCERIN
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 2 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 dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor 

Storage and handling

store between 20-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.5%

Glycerin 33%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic/Analgesic

Demulcent

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.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

  • sore throat is severe, or lasts for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • fever, headache, rash, swelling, nausea or vomiting develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 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 dentist or doctor
  • children under 12 years of age should be supervised in the use of this product
  • children under 2 years of age: consult a dentist or doctor 

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue # 1, FD&C red #40, flavor, purified water, saccharin sodium, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Chloraseptic® Max Strength active ingredients*

Maximum Strength† 

SORE THROAT SPRAY

Phenol, Oral Pain Reliever

Glycerin, Demulcent

Fast Acting Sore Throat Relief

Berry Flavored

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc, distributor of Chloraseptic® Max Strength.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing. For Lot and Expiration Date, see bottom of bottle. Keep cap on when not in use.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2026 CVS/pharmacy CVS.com®

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Sore Throat Spray Berry Flavor
CVS Sore Throat Spray Berry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101852glycerin 33 % / phenol 1.5 % Mucosal SprayPSN2
1101852glycerin 330 MG/ML / phenol 15 MG/ML Mucosal SpraySCD2
1101852glycerin 33 % / phenol 1.5 % Mucosal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-199-04Sore Throat118 mL in 1 BOTTLE, SPRAYSPRAY1182

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-19951316-199-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVACTIB
GLYCERINPDC6A3C0OXACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-22monthly-update2026-06-03 17:46:36

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
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
ndc (package): 51316-199-04
ndc (product): 51316-199
ndc11 (package): 51316019904
spl id: aedc6546-b604-468c-8a1b-f89e871f9d31
spl set id: 9683bcfb-2f7e-48a4-aa79-500ee8df099a

Reported adverse events (FAERS/openFDA)#

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