FDA.reportPublic FDA data

PHE-PLP A&E Deep Throat Desensitizing Spray-strawberry

Manufacturer
Phe Inc
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:18

Label at a glance#

ProductA and E Deep Throat Desensitizing SprayStrawberry
Active ingredientBENZOCAINE
Label structure9 sections

Dosage and administration

■ adults 18 years of age and older: Apply 2–3 sprays to the back of the throat. Limit use to 3–4 times per day. ■ For adults only. Not for sale to minors.

Storage and handling

Store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 3%

Purpose

OTC - PURPOSE SECTION

Desensitizer

Use

INDICATIONS & USAGE SECTION

For occasional personal use to help prevent the gag reflex.

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ■ pale, gray, or blue colored skin (cyanosis) ■ headache ■ rapid heart rate ■ shortness of breath ■ dizziness or lightheadedness ■ fatigue or lack of energy

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults 18 years of age and older: Apply 2–3 sprays to the back of the throat. Limit use to 3–4 times per day.
■ For adults only. Not for sale to minors.

Other information

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Alcohol, Acesulfame Potassium, Sucralose, Potassium Sorbate, Sodium Benzoate, Citric Acid, Flavor.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87068-183-11A and E Deep Throat Desensitizing SprayStrawberry30 mL in 1 BOTTLESPRAY301

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87068-18387068-183-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
ALCOHOL3K9958V90MIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

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
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
ndc (package): 87068-183-11
ndc (product): 87068-183
ndc11 (package): 87068018311
spl id: 4355dab1-a294-ded6-e063-6394a90af9b0
spl set id: 4355dab1-a293-ded6-e063-6394a90af9b0

Reported adverse events (FAERS/openFDA)#

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