Chloraseptic Spray

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2025-09-26
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:14:46

Label at a glance#

ProductChloraseptic Sore Throat Citrus
Active ingredientPHENOL
Label structure28 sections

Indications and uses

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

Dosage and administration

Adults and children 3 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 or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary 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 give to children under 3 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 doctor or dentist if

OTC - ASK DOCTOR 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 health care 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 3 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 or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Other information

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77 °F). Do not refrigerate.
  • Check expiration date before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary 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 give to children under 3 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 doctor or dentist if

OTC - ASK DOCTOR SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens

fever, headache, swelling, rash, nausea or vomiting develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 3 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 or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Other information

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77 °F). Do not refrigerate.
  • check expiration date before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, flavors, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary 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 give to children under 3 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 doctor or dentist if

OTC - ASK DOCTOR 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 health care 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 3 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 or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Other information

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77 °F). Do not refrigerate.
  • check expiration date before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic® 
Phenol/Oral Anesthetic 

CITRUS
6 FL OZ (177 mL)

Chloraseptic® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL)Chloraseptic® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic® Phenol/Oral Anesthetic 

CHERRY Flavor

6 FL OZ (177 mL)

Chloraseptic® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL)Chloraseptic® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic® Phenol/Oral Anesthetic 

MENTHOL Flavor| 6 FL OZ (177 mL)

Chloraseptic® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL)Chloraseptic® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101850Chloraseptic 0.5 % Mucosal SprayPSN11
616480phenol 0.5 % Mucosal SprayPSN11
1101850phenol 5 MG/ML Mucosal Spray [Chloraseptic Spray]SBD11
616480phenol 5 MG/ML Mucosal SpraySCD11
1101850Chloraseptic 0.5 % Mucosal SpraySY11
1101850Chloraseptic Spray 5 MG/ML Mucosal SpraySY11
616480phenol 0.5 % Mucosal SpraySY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-111-31Chloraseptic Sore Throat Cherry177 mL in 1 BOTTLE, SPRAYSPRAY17711
67172-112-31Chloraseptic Sore Throat Citrus177 mL in 1 BOTTLE, SPRAYSPRAY17711
67172-113-31Chloraseptic Sore Throat Menthol177 mL in 1 BOTTLE, SPRAYSPRAY17711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TV2
PHENOLACTIVE MOIETY339NCG44TV2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9X2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-11267172-112-31
67172-11167172-111-31
67172-11367172-113-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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 13 · 774 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
132 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route
150 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
132 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii+route
150 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE / ORAL40 mgExact identifier — unii+route
66 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii+route
150 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii+route
126 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii+route
150 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii+route
150 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
132 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii+route
126 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE / ORAL20 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
132 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
150 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XTABLET / ORAL0.03 mgExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii+route
150 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
126 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
126 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XSOLUTION / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii+route
150 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii+route
126 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii+route
150 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
150 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
132 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii+route
150 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii+route
126 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii+route
150 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route
150 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
132 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
150 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
150 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
132 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii+dosage form
150 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSYRUP / ORAL4 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route
150 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route
126 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii+route
150 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii+route
150 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route
132 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
132 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii+route
126 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route
126 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route
132 equally ranked IID candidates
D&C GREEN NO. 5D&C GREEN NO. 58J6RDU8L9XCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 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
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
ndc (package): 67172-112-31
ndc (package): 67172-111-31
ndc (package): 67172-113-31
ndc (product): 67172-111
ndc (product): 67172-112
ndc (product): 67172-113
ndc11 (package): 67172011231
ndc11 (package): 67172011131
ndc11 (package): 67172011331
spl id: 7013a023-7366-4c7a-b25b-c76942be98a5
spl set id: d5d62f7a-8f92-4d42-a2fb-691f896f72fc

Reported adverse events (FAERS/openFDA)#

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