Capsaicin 0.075 Percent

Product NDC: 50488-1075
Requested package NDC: 50488-1075-1
11-digit product format: 504881075
Labeler code: 50488
Product ID: 50488-1075_3ae88574-9ead-47c7-a71c-d561050df66f
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: Alexso, Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-08
Substance: CAPSAICIN
Active strength: .075 g/100g
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 0.075 Percent
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.075 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
141868	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
33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	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
50488-1075-1	Capsaicin 0.075 Percent	120 g in 1 BOTTLE	CREAM	120		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50488-1075-1	GM - Gram	50488-1075	ca2e0cfb-0513-43de-9652-ad5235a7717e	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50488-1075	CAPSAICIN 0.075 PERCENT (CAPSAICIN) CREAM [ALEXSO, INC]	3	Current NDC, Legacy NDC, 1 package rows	20240719_33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd.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 133 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier application number: M017
TIGER Balm PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	ca601b02-e9be-4d8d-a384-c62553302ceb	2024-04-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier application number: M017
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier application number: M017
HealthWise Capsaicin Heat Patch	CAPSAICIN	Veridian Healthcare	150c1f09-8aa7-67ea-e063-6294a90a950a	2024-04-01	Warnings	Exact identifier application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier application number: M017
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	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
141868	capsaicin 0.075 % Topical Cream	PSN	33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	3
141868	capsaicin 0.75 MG/ML Topical Cream	SCD	33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	3
141868	capsaicin 0.075 % Topical Cream	SY	33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50488-1075-1	50488107501	120 g in 1 BOTTLE (50488-1075-1)	120 g	2021-12-08	No	No	Current