NDC 60630-077

DenTek Instant Pain Relief Maximum Strength

Benzocaine

DenTek Instant Pain Relief Maximum Strength is a Dental; Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Dentek Oral Care, Inc.. The primary component is Benzocaine.

• Product ID: 60630-077_a37972e7-44fb-4282-a258-69c03de5679c
• NDC: 60630-077
• Product Type: Human Otc Drug
• Proprietary Name: DenTek Instant Pain Relief Maximum Strength
• Generic Name: Benzocaine
• Dosage Form: Liquid
• Route of Administration: DENTAL; TOPICAL
• Marketing Start Date: 2015-07-31
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: DenTek Oral Care, Inc.
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 200 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 60630-077-04

1 VIAL, GLASS in 1 CARTON (60630-077-04) > 3.5 mL in 1 VIAL, GLASS (60630-077-03)

• Marketing Start Date: 2015-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60630-077-03 [60630007703]

DenTek Instant Pain Relief Maximum Strength LIQUID

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-31

NDC 60630-077-01 [60630007701]

DenTek Instant Pain Relief Maximum Strength LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-01

NDC 60630-077-02 [60630007702]

DenTek Instant Pain Relief Maximum Strength LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-01
• Inactivation Date: 2019-11-27

NDC 60630-077-04 [60630007704]

DenTek Instant Pain Relief Maximum Strength LIQUID

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	200 mg/mL

OpenFDA Data

• SPL SET ID: 3a3468b4-0625-71cd-e054-00144ff8d46c
• Manufacturer:
  • DenTek Oral Care, Inc.
• UNII:
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 543806
• UPC Code:
  • 0047701003527

NDC Crossover Matching brand name "DenTek Instant Pain Relief Maximum Strength" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
67659-410	DenTek Instant Pain Relief Maximum Strength	DenTek Instant Pain Relief Maximum Strength
60630-077	DenTek Instant Pain Relief Maximum Strength	DenTek Instant Pain Relief Maximum Strength
0283-0220	HurriCaine	Benzocaine
0283-0293	HurriCaine	Benzocaine
0283-0520	HurriCaine	Benzocaine
0283-0569	HurriCaine	Benzocaine
0283-0679	HurriCaine	Benzocaine
0283-0871	HurriCaine	BENZOCAINE
0283-0886	HurriCaine	Benzocaine
0283-0914	HurriCaine	Benzocaine
0283-0920	HurriCaine	Benzocaine
0283-0998	HurriCaine	Benzocaine
0283-1016	HurriCaine	BENZOCAINE