NDC 63135-581

TOPICAINE 5

Lidocaine 5%

TOPICAINE 5 is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Esba Laboratories Inc.. The primary component is Lidocaine.

• Product ID: 63135-581_7f823d69-1b64-73d7-e053-2991aa0a262d
• NDC: 63135-581
• Product Type: Human Otc Drug
• Proprietary Name: TOPICAINE 5
• Generic Name: Lidocaine 5%
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2003-04-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: ESBA LABORATORIES INC.
• Substance Name: LIDOCAINE
• Active Ingredient Strength: 5 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63135-581-04

113 g in 1 TUBE (63135-581-04)

• Marketing Start Date: 2008-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63135-581-13 [63135058113]

TOPICAINE 5 GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2003-04-20

NDC 63135-581-04 [63135058104]

TOPICAINE 5 GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2008-03-01

NDC 63135-581-30 [63135058130]

TOPICAINE 5 GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2003-04-20

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	5 g/100g

OpenFDA Data

• SPL SET ID: 15d33ff7-34ed-253d-e054-00144ff88e88
• Manufacturer:
  • ESBA LABORATORIES INC.
• UNII:
  • 98PI200987
• RxNorm Concept Unique ID - RxCUI:
  • 1652108
  • 1652104
• UPC Code:
  • 0363135581302

NDC Crossover Matching brand name "TOPICAINE 5" or generic name "Lidocaine 5%"

NDC	Brand Name	Generic Name
63135-581	TOPICAINE 5	LIDOCAINE 5%
24357-702	Anecream 5	Lidocaine 5%
70942-183	Doctor Butlers Numb It All Cream	Lidocaine 5%
72839-265	Formula 2 Skin Care	Lidocaine 5%
42291-400	Lidocaine	Lidocaine 5%
0363-4530	Lidocaine 5%	Lidocaine 5%
42858-118	Lidocaine 5%	Lidocaine 5%
63629-2472	Lidocaine 5%	Lidocaine 5%
68752-015	Lidocaine 5%	Lidocaine 5%
70518-3522	Lidocaine 5%	Lidocaine 5%
72275-716	Lidovix L	Lidocaine 5%
63135-811	LIPOCAINE 5	LIDOCAINE 5%
63135-924	LUBRICAINE 5	LIDOCAINE 5%
82429-203	NUMB	Lidocaine 5%
72839-141	Rectal Care Cream	Lidocaine 5%
69315-301	RectaSmoothe	Lidocaine 5%
11822-0265	Rite Aid Rectal Care	Lidocaine 5%
57483-108	Xyralid	Lidocaine 5%