Sore Throat Spray Drug Facts

Manufacturer
Chain Drug Consortium
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:31:24

Label at a glance#

ProductSore Throat Relief Menthol
Active ingredientPHENOL
Label structure9 sections

Indications and uses

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Dosage and administration

  Adults and children 6 years of age and older: • 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   Children 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

• 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

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a 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 right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older:
  • 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
  • Children 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

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature
  • Check expiration date before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Green #5, D&C Yellow #10, FD&C Green #3, flavor, glycerin, purified water, sucralose

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Chloraseptic®*

Sore Throat Relief

Menthol Flavor

Fast acting relief of Minor Sore Throat and Mouth Pain

Phenol/Oral Anesthetic

Sugar-Free

Aspirin-Free

Gluten-Free

Alcohol-Free

6 FL OZ (177 mL)

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

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

DISTRIBUTED BY:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value Sore Throat Spray Menthol Flavor
Premier Value Sore Throat Spray Menthol Flavor

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-343-06Sore Throat ReliefMenthol177 mL in 1 BOTTLE, SPRAYSPRAY1777

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-343SORE THROAT RELIEF MENTHOL (PHENOL) SPRAY [CHAIN DRUG CONSORTIUM]7Current NDC, Legacy NDC, 1 package rows20241030_af661ef0-cdc3-4146-8ae5-59795aa49650.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TV1
PHENOLACTIVE MOIETY339NCG44TV1
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9X1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-34368016-343-06

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 152 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, EXTENDED RELEASE / ORAL0.16 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XTABLET, COATED / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XTABLET, COATED / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET / ORAL240 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET, COATED / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, COATED / ORAL2.5 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, LIQUID FILLED / ORAL0.03 mgExact identifier — unii+route
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii+dosage form
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii+dosage form
38 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, EXTENDED RELEASE / ORAL0.16 mgExact identifier — unii+route
22 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XTABLET / ORAL0.03 mgExact identifier — unii+route
8 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XSOLUTION / ORALNAExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION / ORAL20 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE / ORAL20 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route
42 equally ranked IID candidates

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 Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
ndc (package): 68016-343-06
ndc (product): 68016-343
ndc11 (package): 68016034306
spl id: 3b6b7860-57f5-4479-8d4b-bed4e2ec9f06
spl set id: af661ef0-cdc3-4146-8ae5-59795aa49650

Reported adverse events (FAERS/openFDA)#

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