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 145 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	Warnings	Exact identifier application number: M017
PURE EASE Joint Muscle lnstant Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	42bf129c-5c84-4331-b6d0-78e3be71a985	2023-11-13	Warnings	Exact identifier application number: M017
PURE EASE Neur Cream Instant Deep Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	e46a4636-6405-440a-a05a-862c354bab54	2023-11-13	Warnings	Exact identifier application number: M017
Cryomax Cooling	MENTHOL	LIFE WEAR TECHNOLOGIES	0a0ae5ba-9fac-45f6-e063-6294a90ad555	2023-11-13	Warnings	Exact identifier application number: M017
LBri Super Aloe Stop The Pain	METHYL SALICYLATE, MENTHOL, CAPSAICIN	L'Bris, Pure 'N Natural	8fb2010c-c34b-4552-858d-a0188ad313ad	2023-11-11	Warnings	Exact identifier application number: M017
TOTAL RELIEF	HYDROCORTISONE	DR. MARDER SKINCARE, LLC	2c05459c-5a2c-45ab-b534-87f966b41681	2023-11-11	Warnings	Exact identifier application number: M017
Human Science Muscle Pain Relief	METHYL SALICYLATE, MENTHOL	Human Science, LLC	4bccc017-264b-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma, LLC	55108ffd-d6a8-41de-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
Debbies Down and Dirty Deep Tissue Joint and Muscle	MENTHOL	DD&D Manufacturing Co., Ltd	531fe834-53e3-305f-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
TerraFreeze Pain Relief	MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE	Beyond Derma, LLC	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2023-11-11	Warnings	Exact identifier application number: M017
GOLD ICE Pain Relief	MENTHOL	Eden's Answers, Inc.	a1356c39-42b9-4bd8-a873-bcd40717058b	2023-11-11	Warnings	Exact identifier application number: M017
RUBBING DOTS NATURAL COOL PAIN RELIEF	MENTHOL	Awesome Trading, LLC	137a88ff-e409-4a67-addc-883194c356ae	2023-11-11	Warnings	Exact identifier application number: M017
MAXOCAINE Lidocaine Hemp Oil Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Prime Commerce, LLC	28ed2149-38d2-4062-8442-990a98a69cfc	2023-11-11	Warnings	Exact identifier application number: M017
MAXOCAINE PAIN RELIEVING ROLL-ON	LIDOCAINE HYDROCHLORIDE, MENTHOL	Prime Commerce, LLC	c263d5f2-89b9-4dfd-91c8-f894e5f956c9	2023-11-11	Warnings	Exact identifier application number: M017
SUGAR BRANDS Rescue Pain Relief and Recovery	LIDOCAINE HYDROCHLORIDE	Sugar Brands, LLC	74013709-d1d5-4425-825d-eee726718c61	2023-11-11	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