NDC 62565-903

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM

Benzocaine, Butamben, Tetracaine Hydrochloride

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM is a Dental; Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Hager Worldwide, Inc.. The primary component is Benzocaine; Butamben; Tetracaine Hydrochloride.

• Product ID: 62565-903_b86fa8eb-3daa-4f1d-bbbe-6a87b21f13a9
• NDC: 62565-903
• Product Type: Human Prescription Drug
• Proprietary Name: ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM
• Generic Name: Benzocaine, Butamben, Tetracaine Hydrochloride
• Dosage Form: Gel
• Route of Administration: DENTAL; TOPICAL
• Marketing Start Date: 2009-02-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: HAGER WORLDWIDE, INC.
• Substance Name: BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
• Active Ingredient Strength: 28 mg/.2g; mg/.2g; mg/.2g
• Pharm Classes: Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 62565-903-01

1 JAR in 1 BOX (62565-903-01) > 32 g in 1 JAR

• Marketing Start Date: 2009-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62565-903-01 [62565090301]

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-02-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	28 mg/.2g

OpenFDA Data

• SPL SET ID: 45c23713-43da-45b7-bec4-85127e34ca7c
• Manufacturer:
  • HAGER WORLDWIDE, INC.
• UNII:
  • U3RSY48JW5
  • EFW857872Q
  • 5NF5D4OPCI
• RxNorm Concept Unique ID - RxCUI:
  • 308645
  • 885585

Pharmacological Class

• Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]

NDC Crossover Matching brand name "ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM" or generic name "Benzocaine, Butamben, Tetracaine Hydrochloride"

NDC	Brand Name	Generic Name
62565-902	ONE TOUCH ADVANCED TOPICAL ANESTHETIC	BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
62565-903	ONE TOUCH ADVANCED TOPICAL ANESTHETIC	BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
62565-904	ONE TOUCH ADVANCED TOPICAL ANESTHETIC	BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
62565-901	ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL	BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE