Capsaicin 0.035% cream

Product NDC: 82461-417
11-digit product format: 824610417
Labeler code: 82461
Product ID: 82461-417_0371fc78-d964-4a3c-a2c3-7a1f6e8ad18a
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: Medcore LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-04
Substance: CAPSAICIN
Active strength: .35 mg/mL
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 0.035% cream
Listing expiration: 2027-12-31

Active Ingredients#

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

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
0236e1e4-c26c-4fff-a83b-143ce26d93bf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82461-417-10	Capsaicin 0.035% cream	100 mL in 1 BOTTLE, PUMP	CREAM	100		1

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 93 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WaxRx EarAcheRx Pain Relieving Drops	4% LIDOCAINE HCL	DOCTOR EASY MEDICAL PRODUCTS, LLC	34156655-8706-f0a4-e063-6294a90acc90	2025-05-01	Warnings	Exact identifier application number: M017
foster and thrive anti itch cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Strategic Sourcing Services LLC	bb08293d-5db8-4cc8-9fe3-bd02061dbeb9	2025-04-30	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee6e48-243e-4ded-e063-6394a90a987d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3304e362-dcda-3f5e-e063-6294a90a7015	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2f2f753d-c791-e863-e063-6394a90aec5d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3162c96a-061d-2971-e063-6394a90a9b74	2025-04-29	Warnings	Exact identifier application number: M017
Ivarest Poison Ivy Removal and Itch Relief	PRAMOXINE HYDROCHLORIDE	Blistex Inc.	dedbf5d9-0f86-4f32-8321-da86c9838c0a	2025-04-29	Warnings	Exact identifier application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-on	MENTHOL	Veridian Healthcare	33dae8a8-4197-f276-e063-6294a90aea83	2025-04-28	Warnings	Exact identifier application number: M017
HealthWise Roll-on Menthol Pain Relief Gel	MENTHOL	Veridian Healthcare	33dbb939-9397-7e70-e063-6294a90ac8f4	2025-04-28	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	fa1a98bc-c233-410d-a20e-71111c897372	2025-04-28	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Medcore LLC	b961906c-fe66-466b-af2c-072781fa098b	2025-04-28	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Knee and Elbow	LIDOCAINE	Walgreen Co.	a3fb4c78-1493-4ba4-ae83-502dd825ed67	2025-04-25	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Back	LIDOCAINE	Walgreen Co.	e6bfd342-c0db-46b9-b5e6-5acbd860adf1	2025-04-25	Warnings	Exact identifier application number: M017
Electrum Numb Foam	LIDOCAINE HCI	RENU LABORATORIES, LLC	c8472932-28b7-9189-e053-2a95a90a44df	2025-04-25	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	66a2fd60-1757-45cc-a195-ecb9241dca2a	2025-04-24	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	3385cddb-609f-62e8-e063-6294a90add81	2025-04-24	Warnings	Exact identifier application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2bd8aae0-2606-c7f2-e063-6294a90a9a20	2025-04-22	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	0236e1e4-c26c-4fff-a83b-143ce26d93bf	1
577395	capsaicin 0.35 MG/ML Topical Cream	SCD	0236e1e4-c26c-4fff-a83b-143ce26d93bf	1
577395	capsaicin 0.035 % Topical Cream	SY	0236e1e4-c26c-4fff-a83b-143ce26d93bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82461-417-10	82461041710	100 mL in 1 BOTTLE, PUMP (82461-417-10)	100 ml	2026-05-04	No	No	Current