NDC 63135-312

TOPICAINE

Lidocaine 4%

TOPICAINE 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: 63135-312_7f96e980-891f-743d-e053-2a91aa0aea5f
• NDC: 63135-312
• Product Type: Human Otc Drug
• Proprietary Name: TOPICAINE
• Generic Name: Lidocaine 4%
• 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: 4 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63135-312-04

113 g in 1 TUBE (63135-312-04)

• Marketing Start Date: 2003-04-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63135-312-30 [63135031230]

TOPICAINE GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 1996-12-01

NDC 63135-312-04 [63135031204]

TOPICAINE GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2000-05-01

NDC 63135-312-13 [63135031213]

TOPICAINE GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 1996-12-03

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	4 g/100g

OpenFDA Data

• SPL SET ID: 7f96e980-891e-743d-e053-2a91aa0aea5f
• Manufacturer:
  • ESBA LABORATORIES INC.
• UNII:
  • 98PI200987
• RxNorm Concept Unique ID - RxCUI:
  • 1651001
  • 1291672
• UPC Code:
  • 0363135312135

NDC Crossover Matching brand name "TOPICAINE" or generic name "Lidocaine 4%"

NDC	Brand Name	Generic Name
63135-312	TOPICAINE	LIDOCAINE 4%
24357-701	Anecream	Lidocaine 4%
70518-0795	Anecream	Lidocaine 4%
24357-703	Blue Tube	Lidocaine 4%
69842-050	Burn Relief	Lidocaine 4%
71101-917	Caring Mills Relief Patch with Lidocaine	Lidocaine 4%
52316-031	Frost Lidocaine with Aloe	Lidocaine 4%
42291-399	Lidocaine	Lidocaine 4%
70512-014	Lidocaine 4% Patch	Lidocaine 4%
0395-9130	Lidocaine Pain Relief Roll-On	Lidocaine 4%
69842-029	Lidocaine Pain Relief Roll-On	Lidocaine 4%
63135-727	LUBRICAINE	LIDOCAINE 4%
11822-7799	Medicated Pain Relief Foot	Lidocaine 4%
69842-049	Pain Relief	Lidocaine 4%
49436-099	Recovery Numb	LIDOCAINE 4%
0536-1357	Rugby Lidocaine	Lidocaine 4%
71101-916	THERA CARE 24hrs Lidocaine Patch	LIDOCAINE 4%
0363-9943	Walgreens 24-Hour Lidocaine Patch	Lidocaine 4%
0363-3038	Walgreens pain relieving	Lidocaine 4%
0363-3037	Walgreens Pain Relieving Cream	Lidocaine 4%