FDA.reportPublic FDA data

ABC Sore Throat Spray Sugar Free

Manufacturer
AMERISOURCE BERGEN
Effective date
2026-07-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-07-18 05:10:28

Label at a glance#

ProductABC Sore Throat Menthol Flavor
Active ingredientPHENOL
Label structure9 sections

Indications and uses

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

Dosage and administration

▪ Adults and children 12 year 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 or as directed by a doctor or dentist ▪ Children 6 years to under 12 of age: Should be supervised in use of this product. ▪ Children under 6 years : 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 pain reliever

Uses

INDICATIONS & USAGE SECTION

For the temporarily relieves 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 doctor.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor or dentist 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 12 year 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 or as directed by a doctor or dentist

  • Children 6 years to under 12 of age: Should be supervised in use of this product.
  • Children under 6 years: 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

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Chloraseptic®

NDC# 46122-749-76

SORE

THROAT

SPRAY

Phenol / Oral Pain Reliever

  • Fast Acting
  • Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

MENTHOL FLAVOR

Naturally and Artificially Flavored

6 FL OZ. (177 mL)

*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn.

ABC Sore Throat Spray 6 fl Oz. (177 mL) Mentol Flavor
ABC Sore Throat Spray 6 fl Oz. (177 mL) Mentol Flavor

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-749-76ML - Milliliter46122-7498abd735a-12a6-4fa5-ae80-fba76af0dcf312023-10-16

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
46122-74946122-749-76

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
FD&C GREEN NO. 33P3ONR6O1SIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-09full-release2026-06-01 01:06:49

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
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
ndc (package): 46122-749-76
ndc (product): 46122-749
ndc11 (package): 46122074976
spl id: 73ce6d42-7080-403a-9705-887f23bba142
spl set id: 9d9baf58-4790-4ff4-a462-5eb70c0e80c5

Reported adverse events (FAERS/openFDA)#

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