NDC 64058-358

Omega 3

Capsaicin

Omega 3 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Concept Laboratories, Inc.. The primary component is Capsaicin.

• Product ID: 64058-358_4b7aefe7-9302-48d5-b4a0-e8b9aefe36cf
• NDC: 64058-358
• Product Type: Human Otc Drug
• Proprietary Name: Omega 3
• Generic Name: Capsaicin
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-11-16
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Concept Laboratories, Inc.
• Substance Name: CAPSAICIN
• Active Ingredient Strength: 0 ug/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 64058-358-12

59 mL in 1 BOTTLE (64058-358-12)

• Marketing Start Date: 2016-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64058-358-18 [64058035818]

Omega 3 CREAM

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-11-16

NDC 64058-358-12 [64058035812]

Omega 3 CREAM

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-11-16

Drug Details

Active Ingredients

Ingredient	Strength
CAPSAICIN	.025 ug/mL

OpenFDA Data

• SPL SET ID: 28149005-1359-40bc-bda0-07acef7efeb3
• Manufacturer:
  • Concept Laboratories, Inc.
• UNII:
  • S07O44R1ZM

NDC Crossover Matching brand name "Omega 3" or generic name "Capsaicin"

NDC	Brand Name	Generic Name
64058-353	Omega 3	Omega 3
64058-358	Omega 3	Omega 3
64058-354	Omega 3	Omega 3
41167-1920	Aspercreme Warming	Capsaicin
11993-000	ASTRAPHARM CHILLI BRAND	CAPSAICIN
11993-001	ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED	Capsaicin
28691-0025	Capsaicin	Capsaicin
0363-9902	CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	CAPSAICIN
11822-4210	CAPSAICIN HEAT PATCHES PAIN RELIEF	CAPSAICIN
0395-0130	Castiva Warming	Capsaicin
24286-1559	EARTHS CARE ARTHRITIS	CAPSAICIN
35192-040	Kanjo Natural Pain relief oil	Capsaicin
37205-641	LEADER CAPSAICIN	CAPSAICIN
15478-141	Neuriterx 0.05%	CAPSAICIN
10144-928	Qutenza	capsaicin
10144-929	Qutenza	capsaicin
11822-5744	RITE AID CAPSICUM HOT	CAPSAICIN
11822-7448	RITE AID CAPSICUM HOT	CAPSAICIN
0536-1118	Rugby Arthritis Pain Relieving	Capsaicin
0536-2525	Rugby Capsaicin	Capsaicin
0536-1264	Rugby Capsaicin Cream	Capsaicin
0363-0837	Walgreens Arthritis Pain Relief Capsaicin Analgesic	Capsaicin
35192-023	Weh-Weh Natural Pain relief oil	Capsaicin
10742-8126	WellPatch Capsaicin Pain Relief	Capsaicin
14785-8126	WellPatch Capsaicin Pain Relief	Capsaicin
10742-8127	WellPatch Warming Pain Relief	capsaicin