Search by Drug Name or NDC

NDC 66467-4001-02 BENZOCAINE 220 mg/g Details

BENZOCAINE 220 mg/g

BENZOCAINE is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Darby Dental Supply, LLC. The primary component is BENZOCAINE.

Product Information

NDC	66467-4001
Product ID	66467-4001_d66bec35-1e0b-177d-e053-2995a90ac0be
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BENZOCAINE
Proprietary Name Suffix	Bubble Gum
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	220
Active Ingredient Units	mg/g
Substance Name	BENZOCAINE
Labeler Name	Darby Dental Supply, LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 66467-4001-02 (66467400102)

Pricing Information	N/A
NDC Package Code	66467-4001-2
Billing NDC	66467400102
Package	30 g in 1 JAR (66467-4001-2)
Marketing Start Date	1963-02-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dd805400-26c5-4c18-ade2-821298233f9b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

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 the 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

Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Do not use

for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
for teething
in children under 2 years of age

When using this product

Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a physician before use.

Keep out of reach of children.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.
children under 2 years of age: do not use

Other information

Store at 59° - 86°F (15 - 30°C). Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

800-645-2310 or darby.com

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada

DARBY®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada

INGREDIENTS AND APPEARANCE

BENZOCAINE CHERRY

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4002
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4002-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

BENZOCAINE MINT

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4003
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4003-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

BENZOCAINE BUBBLE GUM

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4001-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

BENZOCAINE STRAWBERRY

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4006
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4006-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

BENZOCAINE RASPBERRY

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4000
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4000-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

BENZOCAINE PINA COLADA

benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66467-4004
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	white (DYE FREE)	Score
Shape		Size
Flavor	COCONUT (Pina Colada)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-4004-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/19/1963

Labeler - Darby Dental Supply, LLC (825137818)

Registrant - DSHealthcare (056296981)

Name	Address	ID/FEI	Business Operations
Establishment
Keystone Industries		014769301	manufacture(66467-4000, 66467-4001, 66467-4002, 66467-4003, 66467-4004, 66467-4006)

Revised: 1/2022

Document Id: d66bec35-1e0b-177d-e053-2995a90ac0be

Set id: dd805400-26c5-4c18-ade2-821298233f9b

Version: 3

Effective Time: 20220125

Search by Drug Name or NDC

NDC 66467-4001-02 BENZOCAINE 220 mg/g Details

BENZOCAINE 220 mg/g

Product Information

Package

Package Images

NDC 66467-4001-02 (66467400102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dd805400-26c5-4c18-ade2-821298233f9b Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Use

Warnings

Methemoglobinemia warning

Allergy Alert

Do not use

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry

PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?