Capsaicin 0.1% Cream

Product NDC: 59088-242
11-digit product format: 590880242
Labeler code: 59088
Product ID: 59088-242_4e83442a-1ace-3a67-e063-6294a90a93df
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin 0.1%
Dosage form: CREAM
Route: TOPICAL
Labeler: Puretek Corporation
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-03
Substance: CAPSICUM OLEORESIN
Active strength: 1 mg/g
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 0.1% Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSICUM OLEORESIN	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UW86K581WY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
646333	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4e83441b-cb6a-beb0-e063-6394a90a1b54	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-242-08	Capsaicin 0.1% Cream	120 g in 1 BOTTLE, PUMP	CREAM	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59088-242-08	GM - Gram	59088-242	79f9703e-e320-44f6-9fa4-fe8bd1319f33	1	2026-05-22

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 104 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocare Arm, Neck, Leg	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	59a104ee-7034-99c3-e053-2991aa0a164c	2025-01-06	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare 03	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	416ebf5a-2efb-6d0b-e054-00144ff88e88	2025-01-06	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll-on	MENTHOL	ADP Health Limited	e0bb77b2-45ee-45fa-9659-9c7d99bb20dc	2025-01-05	Warnings	Exact identifier application number: M017
health and beyond BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b6bb3ed-50fb-40c4-acb6-ae3f16031531	2025-01-05	Warnings	Exact identifier application number: M017
glo SKIN BEAUTY Remedy Gel	GLO SKIN BEAUTY REMEDY GEL	Hayden Caleel LLC	aa47ff08-07b3-4fd1-bae5-420e4b928f06	2025-01-05	Warnings	Exact identifier application number: M017
Capsaicin 0.025% Cream	CAPSAICIN 0.025%	Puretek Corporation	28f00df0-c416-f17b-e063-6294a90a5570	2025-01-02	Warnings	Exact identifier application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	Tai Guk Pharm. Co., Ltd.	8f29ffd7-48b9-109f-e053-2995a90ab215	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Arthritis Pain Relief Cream Capsaisin	CAPSAISIN	Tai Guk Pharm. Co., Ltd.	8f286a9d-8765-21b3-e053-2a95a90ae43a	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Exact identifier application number: M017
HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	b9d033f3-4d12-a2c8-e053-2995a90ac7f1	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief with Menthol	MENTHOL	Green Compass, Inc.	0a0c212e-ae5d-8505-e063-6394a90af622	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
OKeeffes Working Hands Pain Relief Skin Protectant	ALLANTOIN, LIDOCAINE HYDROCHLORIDE	The Gorilla Glue Company/O'Keeffe's Company	0685da25-c9fa-e1cd-e063-6394a90ae1b3	2025-01-01	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine Pain Relieving	LIDOCAINE HCL AND MENTHOL	Chattem, Inc.	75b28b06-77ea-4fea-b516-2e8a0dac7037	2025-01-01	Warnings	Exact identifier application number: M017
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Fragrance-Free	HYDROCORTISONE	Lovely Skin, Inc.	c12af4c6-2f05-46ec-b901-1a4fcd750180	2024-12-31	Warnings	Exact identifier application number: M017
Pain Relieving Cream Lidocaine	BENZYL ALCOHOL, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	039a2036-54b2-cf28-e063-6294a90a8ce6	2024-12-31	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief Walgreens	MENTHOL 10.5%	WALGREEN COMPANY	f1daa68d-1b12-c28a-e053-2995a90a0949	2024-12-31	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UW86K581WY	CAPSICUM OLEORESIN	8023-77-6	CAPSICUM OLEORESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
646333	capsaicin 0.1 % Topical Cream	PSN	4e83441b-cb6a-beb0-e063-6394a90a1b54	1
646333	capsaicin 1 MG/ML Topical Cream	SCD	4e83441b-cb6a-beb0-e063-6394a90a1b54	1
646333	capsaicin 0.1 % Topical Cream	SY	4e83441b-cb6a-beb0-e063-6394a90a1b54	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59088-242-08	59088024208	120 g in 1 BOTTLE, PUMP (59088-242-08)	120 g	2026-04-03	No	No	Current