Capsaicin

Product NDC: 50488-1025
11-digit product format: 504881025
Labeler code: 50488
Product ID: 50488-1025_1eb282ca-46c9-4da5-b2e8-40819f4a6677
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: Alexso, Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-10-01
Substance: CAPSAICIN
Active strength: .025 g/100g
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.025 g/100g

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
198555	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
433da27d-04fb-481a-bbb0-874bb72c806a	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	SPL version
50488-1025-1	Capsaicin	1 in 1 CARTON	CREAM	1	6
50488-1025-1	Capsaicin	120 g in 1 TUBE	CREAM	120	6
50488-1025-2	Capsaicin	1 in 1 CARTON	CREAM	1	6
50488-1025-2	Capsaicin	25 g in 1 TUBE	CREAM	25	6
50488-1025-5	Capsaicin	1 in 1 CARTON	CREAM	1	6
50488-1025-5	Capsaicin	50 g in 1 TUBE	CREAM	50	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50488-1025-1	GM - Gram	50488-1025	d17846c1-27c2-4422-951e-81c30af4e47b	1	2018-11-06
50488-1025-2	GM - Gram	50488-1025	990eddfb-a7a5-4493-b6e9-371140c2fd9d	1	2019-10-07
50488-1025-5	GM - Gram	50488-1025	9795f0e9-7933-4d81-9bc2-c7b3efa42c38	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50488-1025	CAPSAICIN CREAM [ALEXSO, INC]	6	Current NDC, Legacy NDC, 6 package rows	20241208_433da27d-04fb-481a-bbb0-874bb72c806a.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 140 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	Warnings	Exact identifier application number: M017
XRay Pain Relief	MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE	Genomma Lab USA	5244ddee-fd9e-4df3-8fb3-b16aa321a316	2023-12-27	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Pharma Nobis, LLC	e42fbe63-b01c-4f85-e053-2a95a90a5143	2023-12-26	Warnings	Exact identifier application number: M017
Equate Calaspray	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Walmart Inc	027ed5ab-05ec-569f-e063-6394a90abbc3	2023-12-26	Warnings	Exact identifier application number: M017
EXTERNAL ANALGESIC	CAMPHOR, CAPSICUM, MENTHOL	Hmong 21	3b6155a5-51aa-2780-e054-00144ff8d46c	2023-12-26	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
198555	capsaicin 0.025 % Topical Cream	PSN	433da27d-04fb-481a-bbb0-874bb72c806a	6
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	433da27d-04fb-481a-bbb0-874bb72c806a	6
198555	capsaicin 0.025 % Topical Cream	SY	433da27d-04fb-481a-bbb0-874bb72c806a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50488-1025-1	50488102501	1 TUBE in 1 CARTON (50488-1025-1) / 120 g in 1 TUBE	1 tube	2018-10-01	0000-00-00	No	No	Current
50488-1025-2	50488102502	1 TUBE in 1 CARTON (50488-1025-2) / 25 g in 1 TUBE	1 tube	2018-10-01	0000-00-00	No	No	Current
50488-1025-5	50488102505	1 TUBE in 1 CARTON (50488-1025-5) / 50 g in 1 TUBE	1 tube	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Capsaicin Cream	Alexso, Inc	2024-12-06	HUMAN OTC DRUG LABEL	6
CapsFenac Pak	SA3, LLC	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	4