MedPath

Rexall

5820346 DG Max Str OP Relief Liq

Approved
Approval ID

8f6e2780-cfb7-4bef-9b7d-13cb80d8923e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Rexall

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-346
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (9)

POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
BENZOCAINEActive
Quantity: 20 g in 100 mL
Code: U3RSY48JW5
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/13/2015

Card R3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/13/2015

Directions

Adults and children 2 years of age and older:

  • apply to affect4ed area using applicator tip
  • 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 this product.

Children under 2 years of age: ask a dentist or doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/13/2015

Active ingredient

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/13/2015

Uses

Temporarily relieves pain associated with the following mouth irritations toothache sore gums canker sores braces minor dental procedures

WARNINGS SECTION

LOINC: 34071-1Updated: 1/13/2015

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens swelling rash or fever developes

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/13/2015

Other Information

Do not use if package has been opened

Store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/13/2015

Inactive ingredients

Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/13/2015

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
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 this product.
Children under 2 years of age: ask a dentist or doctor.

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Rexall - FDA Drug Approval Details