Capsaicin 0.035% Cream

Product NDC: 59088-246
11-digit product format: 590880246
Labeler code: 59088
Product ID: 59088-246_3cbc73b6-8c59-8f23-e063-6394a90a71a3
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin 0.035% Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Puretekcorp
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-20
Substance: CAPSAICIN
Active strength: .35 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 0.035% Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S07O44R1ZM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577395	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
3cbc73b6-8c58-8f23-e063-6394a90a71a3	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-246-08	Capsaicin 0.035% Cream	120 g in 1 TUBE	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
59088-246-08	GM - Gram	59088-246	9babf7a1-115f-4b46-8a1d-8c33a1b6f74c	1	2025-09-12

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 100 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Max Strength 1 Hydrocortisone Cream	HYDROCORTISONE	Family Dollar Stores, Inc	bca5ac2c-45cd-44e3-98f1-317a04e44d7d	2025-02-25	Warnings	Exact identifier application number: M017
Tylenol Precise Nighttime Pain Relieving	CAMPHOR, MENTHOL	Kenvue Brands LLC	2ef4fe16-0820-6aad-e063-6294a90a8449	2025-02-25	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Preferred Pharmaceuticals Inc.	c259ef92-5d07-4590-adf1-3a106333eee0	2025-02-21	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll On	MENTHOL	ADP Health Limited	420d8cdc-f47f-4d33-bf25-9033ff266c49	2025-02-19	Warnings	Exact identifier application number: M017
AVCOO Pain Relief	MENTHOL	ADP Health Limited	700ce2cf-749e-40be-91c3-850d9b2168ca	2025-02-19	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	Jell Pharmaceuticals Pvt. Ltd	2e7c49de-5438-4858-e063-6294a90ad98c	2025-02-19	Warnings	Exact identifier application number: M017
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	Warnings	Exact identifier application number: M017
Signature Care Medicated Pain Relief Patch	LIDOCAINE	Safeway, Inc.	2165a342-5f8b-78e0-e063-6394a90a06c4	2025-02-12	Warnings	Exact identifier application number: M017
CheeZheng Pain Relieveing Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd.	abcebdf1-9037-4094-93e1-ce8f20b18ea7	2025-02-11	Warnings	Exact identifier application number: M017
Tibetree Pain Relieveing Medicated Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	4216bd48-5c62-4e87-adcc-67bf7152d64d	2025-02-11	Warnings	Exact identifier application number: M017
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	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
577395	capsaicin 0.035 % Topical Cream	PSN	3cbc73b6-8c58-8f23-e063-6394a90a71a3	1
577395	capsaicin 0.35 MG/ML Topical Cream	SCD	3cbc73b6-8c58-8f23-e063-6394a90a71a3	1
577395	capsaicin 0.035 % Topical Cream	SY	3cbc73b6-8c58-8f23-e063-6394a90a71a3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59088-246-08	59088024608	120 g in 1 TUBE (59088-246-08)	120 g	2025-08-20	No	No	Current