NDC 58443-0263

Solmate Burn Relief Gel

Lidocaine Hydrochloride

Solmate Burn Relief Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Lidocaine.

• Product ID: 58443-0263_7d8fae70-f795-aeec-e053-2a91aa0a77b7
• NDC: 58443-0263
• Product Type: Human Otc Drug
• Proprietary Name: Solmate Burn Relief Gel
• Generic Name: Lidocaine Hydrochloride
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-12-21
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: LIDOCAINE
• Active Ingredient Strength: 7 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0263-7

591 mL in 1 BOTTLE (58443-0263-7)

• Marketing Start Date: 2018-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0263-7 [58443026307]

Solmate Burn Relief Gel GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-12-21

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	7.1258 mg/mL

OpenFDA Data

• SPL SET ID: 7d8f95ee-7cbc-9cc2-e053-2a91aa0a6210
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 98PI200987
• RxNorm Concept Unique ID - RxCUI:
  • 1723988

NDC Crossover Matching brand name "Solmate Burn Relief Gel" or generic name "Lidocaine Hydrochloride"

NDC	Brand Name	Generic Name
58443-0145	Solmate Burn Relief Gel	Solmate Burn Relief Gel
58443-0263	Solmate Burn Relief Gel	Solmate Burn Relief Gel
0143-9575	Lidocaine	Lidocaine Hydrochloride
0143-9576	Lidocaine	Lidocaine Hydrochloride
0143-9577	Lidocaine	Lidocaine Hydrochloride
0143-9578	Lidocaine	Lidocaine Hydrochloride
0143-9579	Lidocaine	LIDOCAINE HYDROCHLORIDE
0054-3505	Lidocaine Hydrochloride	Lidocaine Hydrochloride
0143-9594	Lidocaine Hydrochloride	Lidocaine Hydrochloride
0143-9595	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE
0264-9376	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE
0404-9885	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE
0404-9889	Lidocaine Hydrochloride	Lidocaine Hydrochloride
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride
0338-9586	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride
0338-9590	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride
0054-3500	Lidocaine Viscous	Lidocaine Hydrochloride
0121-0903	Lidocaine Viscous	Lidocaine Hydrochloride
0295-1110	SunBurnt PLUS Pain Relief	Lidocaine Hydrochloride
0363-9919	WALG AFTRSN BURN RELIEF	LIDOCAINE HYDROCHLORIDE
0363-7790	Walgreen Pain Relieving	Lidocaine Hydrochloride
0363-4000	Walgreens Aloe Vera Burn Relief	LIDOCAINE HYDROCHLORIDE
0363-2020	WALGREENS BURN	lidocaine hydrochloride
0363-0290	Walgreens Burn relief	Lidocaine Hydrochloride
0363-0954	Walgreens Cooling	Lidocaine Hydrochloride
0363-0978	Walgreens Sunburn Relief	Lidocaine Hydrochloride