FDA.reportPublic FDA data

Alpha-Caine

Manufacturer
Dental Technologies, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:42:11

Label at a glance#

ProductAlpha-Caine Topical Anesthetic
Active ingredientBENZOCAINE
Label structure16 sections

Indications and uses

For the temporary relief of occasional minor irritation and pain, associated with: Sore mouth and throat Ulcers Minor dental procedures Needle punctures Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage and administration

do not exceed recommended dosage. adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by 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 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

WARNINGS SECTION

For external use only

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

Allergy alert:

OTC - DO NOT USE SECTION

Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

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

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed recommended dosage.

  • adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by 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

Other information

OTHER SAFETY INFORMATION

Store at 59° to 86º F (15º to 30º C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-835-0885 or 1-847-677-5500 M-F 8:00 a.m. – 4:30 p.m. CST.

Visit www.dentaltech.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTAL

TECHNOLOGIES

www.dentaltech.com

ALPHA-CAINE

TOPICAL ANESTHETIC GEL

DENTAL TECHNOLOGIES, INC.

Lincolnwood, IL 60712

Made in U.S.A.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

20% Benzocaine Oral Anesthetic

1oz. (30g)

Alpha-Caine_Cherry_image.jpgAlpha-Caine_Cherry_image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297832ALPHA-CAINE 20 % Oral GelPSN8
238910benzocaine 20 % Oral GelPSN8
1297832benzocaine 0.2 MG/MG Oral Gel [Alpha-caine]SBD8
238910benzocaine 0.2 MG/MG Oral GelSCD8
1297832Alpha-caine 0.2 MG/MG Oral GelSY8
1297832Alpha-caine 20 % Oral GelSY8
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY8

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
55346-2903-1Alpha-CaineTopical Anesthetic30 g in 1 BOTTLE, PLASTICGEL308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW54
BenzocaineACTIVE MOIETYU3RSY48JW54
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L4
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5P4
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55346-290355346-2903-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C RED NO. 339DBA0SBB0LIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72023-11-20full-release2026-06-01 00:04:43

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 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRASYNOVIAL3 %w/vExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAMUSCULAR56 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / RECTAL5704 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SOFT TISSUE87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSPRAY, METERED / NASAL96 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRALESIONAL87 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRASYNOVIAL3 %w/vExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
112 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / DENTALNAExact identifier — unii+route
2 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
8 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAVENOUS0.5 mlExact identifier — unii candidate
112 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
112 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
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ff0695a1-1d7d-4b51-97fd-689e56d914fe2025-11-04WarningsExact identifier
ndc (package): 55346-2903-1
ndc (product): 55346-2903
ndc11 (package): 55346290301
spl id: 42c8954b-41e2-f6c0-e063-6294a90a5929
spl set id: ff0695a1-1d7d-4b51-97fd-689e56d914fe

Reported adverse events (FAERS/openFDA)#

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