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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL BREEZE Pain Relief	MENTHOL	COOL BREEZE US LLC	14dcf4ee-6778-49d4-8601-9205737432ea	2023-11-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	1ebb45e5-4541-4c95-abe1-661ef763a610	2023-11-01	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Cream	LIDOCAINE 4%	Walgreens	ce1b55ed-f5c5-ea8b-e053-2a95a90acd40	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens pain relieving	LIDOCAINE 4%	Walgreens	ce2b9e57-749d-715c-e053-2995a90aaf8d	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens Cool n heat	LIDOCAINE 4% MENTHOL 1%	Walgreens	ce168ab7-ec4a-daea-e053-2995a90af829	2023-10-31	Warnings	Exact identifier application number: M017
Methyl Salicylate 40 Percent	METHYL SALICYLATE	Alexso, Inc	53407aab-094c-4393-a2b9-54fd85321e3e	2023-10-31	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bentlin Products LLC	4346351c-8e11-46ae-b428-98d17f55beb9	2023-10-30	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	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