Capsaicin

Product NDC: 79643-002
11-digit product format: 796430002
Labeler code: 79643
Product ID: 79643-002_5d6ccb0a-8b91-6a86-e063-6294a90ab030
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: PATCH
Route: TOPICAL
Labeler: PHARMACURE LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-02-02
Substance: CAPSAICIN
Active strength: .025 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Capsaicin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.025 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-20	05a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-03-20	05a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-03-20	05a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-30	05a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-30	05a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-30	05a09ee5-e7a4-4758-8b16-f60b945a7d82

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79643-002-01	Capsaicin	100 g in 1 PATCH	PATCH	100		5
79643-002-01	Capsaicin	10 in 1 BOX	PATCH	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79643-002-01	EA - Each	79643-002	9cc62b9f-8597-493c-ae49-9c5caff85cf4	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79643-002	CAPSAICIN PATCH [PHARMACURE LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241220_05a09ee5-e7a4-4758-8b16-f60b945a7d82.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 123 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Asclemed USA, Inc.	1553351c-aee8-4c40-9548-35cce246bda9	2024-10-25	Warnings	Exact identifier application number: M017
Outgro	BENZOCAINE	Medtech Products Inc.	d6be8a1d-aca7-42b1-86da-881d42ffe8d5	2024-10-25	Warnings	Exact identifier application number: M017
Monistat Complete Care Instant Itch Relief	HYDROCORTISONE	Insight Pharmaceuticals LLC	a0f40504-6183-4f32-8d17-6586b3f386a6	2024-10-25	Warnings	Exact identifier application number: M017
Boil Ease	BENZOCAINE	Insight Pharmaceuticals LLC	bf108934-5e1a-4059-9dcf-008f52a83fab	2024-10-25	Warnings	Exact identifier application number: M017
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Exact identifier application number: M017
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Exact identifier application number: M017
Careland Hydrogel Pain Relief Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	e970070c-1c3b-49f0-8298-e6c5ebbf50a0	2024-10-18	Warnings	Exact identifier application number: M017
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Exact identifier application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	LIDOCAINE HCL	CVS Pharmacy	f0f1969d-10e0-76ee-e053-2995a90a7336	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wong To Yick Wood Lock Ointment Ltd	16a21af4-6bc0-4ae1-aa3b-1da84c8286e2	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wicsun Trading Inc	0b4bd444-b3c1-47aa-a7e3-f16c92326124	2024-10-17	Warnings	Exact identifier application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL	LIDOCAINE	Fruit of the Earth, Inc.	c7a833bd-7457-73a3-e053-2a95a90ac53f	2024-10-17	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043399	capsaicin 0.025 % Medicated Patch	PSN	05a09ee5-e7a4-4758-8b16-f60b945a7d82	5
1043399	capsaicin 0.00025 MG/MG Medicated Patch	SCD	05a09ee5-e7a4-4758-8b16-f60b945a7d82	5
1043399	capsaicin 0.025 % Medicated Patch	SY	05a09ee5-e7a4-4758-8b16-f60b945a7d82	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79643-002-01	79643000201	10 PATCH in 1 BOX (79643-002-01) / 100 g in 1 PATCH	10 patch	2021-02-02	0000-00-00	No	No	Current