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 77 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl oz	MENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)	BH GLOBAL HOLDINGS LLC	1ddddbb6-2d01-c894-e063-6394a90acd58	2025-10-01	Warnings	Exact identifier application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%	LIDOCAINE	Kenvue Brands LLC	36a95afd-97e5-2271-e063-6394a90aea18	2025-09-30	Warnings	Exact identifier application number: M017
Capsaicin Heat	CAPSAICIN	Universal Distribution Center LLC	b3b40f77-3b0b-4111-968b-f3a87a5701fa	2025-09-29	Warnings	Exact identifier application number: M017
Caring Mills Menthol 4% Roll-On	MENTHOL	Veridian Healthcare	f4308c74-0860-4265-aeaf-a01301cca27a	2025-09-29	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED LARGE	MENTHOL	Universal Distribution Center LLC	d6780230-aa96-4055-b054-be41358568b6	2025-09-29	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED	MENTHOL	Universal Distribution Center LLC	c19aa620-401d-43c4-804c-3611cc39e9f2	2025-09-29	Warnings	Exact identifier application number: M017
UniShield First Aid Burn	LIDOCAINE HCL	Unishield	f729c557-da4b-3fb5-e053-6394a90a4196	2025-09-28	Warnings	Exact identifier application number: M017
Xpect Hydrocortisone	HYDROCORTISONE	Cintas Corporation	45ef9be4-54c4-4d85-966b-27708313ded4	2025-09-26	Warnings	Exact identifier application number: M017
Zhuifeng Gao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	3f12da60-26d1-4407-8e02-c3213ea3ad2a	2025-09-26	Warnings	Exact identifier application number: M017
Gutong Tiegao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	5a5c3759-90e0-4a93-99cf-ddbf00aba10d	2025-09-26	Warnings	Exact identifier application number: M017
Zhuanggu Gao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	e3e98530-ce4d-47b9-9383-3088814034eb	2025-09-26	Warnings	Exact identifier application number: M017
GUTONG TIEGAO PAIN RELIEVING	CAMPHOR AND MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	3adfac16-ea7b-47df-89f5-91bbd09c4fe1	2025-09-26	Warnings	Exact identifier application number: M017
Xpect Sting Wipes	BENZOCAINE 6%	Cintas Corporation	feeae00d-e266-4ae4-90d2-524da38fa813	2025-09-26	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Walgreens Company	0b4053a8-6c1c-621d-e063-6394a90a4f56	2025-09-25	Warnings	Exact identifier application number: M017
Unishield 1%	HYDROCORTISONE	Unishield	4871a67f-fbb8-4a6b-ace4-d34349028908	2025-09-24	Warnings	Exact identifier application number: M017
Xpect Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cintas Corporation	a373b2c3-5c58-4b64-9358-bdf42dfce08c	2025-09-24	Warnings	Exact identifier application number: M017
Xpect Burn Care	BURN CARE	Cintas Corp	3665eb99-9602-4949-8af4-3ce7ed24303c	2025-09-23	Warnings	Exact identifier application number: M017
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	80a1bc65-2986-491f-a062-307d28b08ccb	2025-09-22	Warnings	Exact identifier application number: M017
TheraCare Roll-on Menthol 16% Pain Relief Liquid	MENTHOL	Veridian Healthcare	d932050d-2a9a-4a5e-b45d-0a7a864582e0	2025-09-22	Warnings	Exact identifier application number: M017
TheraCare Roll-on Menthol 4% Pain Relief	MENTHOL	Veridian Healthcare	fa121e5f-94b5-4c1d-9c4e-85bb8ede3945	2025-09-22	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