SalivaCAINE

Manufacturer
Forward Science Technologies LLC
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:05

Label at a glance#

ProductSalivaCAINE
Active ingredientBENZOCAINE
Label structure12 sections

Indications and uses

For temporary relief of occasional minor oral irritation, oral pain, and sore mouth.

Dosage and administration

Adults and children 2 years of age and older: Mix packet with 0.1oz water and apply the rinse to the affected area. Gargle, swish around in the mouth, or allow to remain in place 1 minute then Spit Out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5% (w/v)

Purpose: oral pain reliever

Uses

INDICATIONS & USAGE SECTION

For temporary relief of occasional minor oral
irritation, oral pain, and sore mouth.

METHEMOGLOBINEMIA WARNING

WARNINGS SECTION

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 • dizziness or lightheadedness
• rapid heart rate • shortness of breath
• fatigue or lack of energy

Allergy alert

WARNINGS SECTION

Do not use this product if you have a history of allergy to local anesthetics such as procaine,
butacaine, benzocaine, or any other ‘caine’ anesthetics. If a skin reaction occurs, stop use and seek
medical help right away.

Sore throat warning

WARNINGS SECTION

If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever
headache, rash, nausea, or vomiting, consult a
doctor promptly. If sore mouth symptoms do
not improve in 7 days, see your dentist or
doctor promptly.

Do Not Use

OTC - DO NOT USE SECTION

Do not use

• for teething

• in children under 2 years of age

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

Mix packet with 0.1oz water and apply the rinse to the affected area. Gargle, swish around in the mouth, or allow to remain in place 1 minute then Spit Out.
Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of the product.

Children under 2 years of age: do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Chloride, Dibasic Sodium Phosphate, Monobasic Sodium
Phosphate, Silicon Dioxide, Sodium Chloride

Questions

OTC - QUESTIONS SECTION

Call 1-855-696-7254 (M - F 8:30 - 5:30 CST)
You may also report side effects to this phone number.

OTC - PURPOSE SECTION

oral pain reliever

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70275-0406-03

SalivaCAINE

Oral Pain Reliever

(Benzocaine 5%)

30 Packets Dissolving Powder

Mix with water before use

Benzocaine 150mg/0.1oz

418mg per packet - 12.54g total

salivacaine_box_pkts_3qtr_rt.jpgsalivacaine_box_pkts_3qtr_rt.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1871473Benzocaine 5 % Powder for Oral SolutionPSN4
1871479SalivaCAINE 5 % Powder for Oral SolutionPSN4
1871479benzocaine 150 MG Powder for Oral Solution [SalivaCAINE]SBD4
1871473benzocaine 150 MG Powder for Oral SolutionSCD4
1871479SalivaCAINE 150 MG Powder for Oral SolutionSY4
1871479SalivaCAINE 5 % Powder for Oral SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70275-406-032022-01-28C16284748780-1d6a99b39-ba3d-a426-e053-dadaa90af4c2SalivaCAINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70275-406-03SalivaCAINE150 mg in 1 PACKETPOWDER, FOR SOLUTION1504
70275-406-03SalivaCAINE30 in 1 CARTONPOWDER, FOR SOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70275-406SALIVACAINE (BENZOCAINE) POWDER, FOR SOLUTION [FORWARD SCIENCE TECHNOLOGIES LLC]4Legacy NDC, 2 package rows20200118_4793e9d8-25fc-00b4-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70275-40670275-406-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
7bacbad2-a161-21c0-e053-2991aa0a19f24793e9d8-25fc-00b4-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 7bacbad2-a161-21c0-e053-2991aa0a19f2
spl set id: 4793e9d8-25fc-00b4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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