Capsaicin Cream

Product NDC: 69396-103
11-digit product format: 693960103
Labeler code: 69396
Product ID: 69396-103_292a33db-d5ab-982c-e063-6394a90aa127
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals USA LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-14
Substance: CAPSAICIN
Active strength: .1 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 Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.1 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
646333	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
def8d341-06a7-0e9b-e053-2995a90a0ad6	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
69396-103-02	Capsaicin Cream	1 in 1 BOX	CREAM	1		4
69396-103-02	Capsaicin Cream	60 g in 1 TUBE	CREAM	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-103	CAPSAICIN CREAM (CAPSAICIN) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241215_def8d341-06a7-0e9b-e053-2995a90a0ad6.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 143 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoidal Pain Relief Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	WALGREENS	03bbe146-f185-bcfa-e063-6394a90a85bf	2023-12-04	Warnings	Exact identifier application number: M017
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Exact identifier application number: M017
TACT	DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL	Sato Pharmaceutical Inc., Ltd.	b6e2ee24-69de-4dfd-9081-b9537b7a7bad	2023-12-04	Warnings	Exact identifier application number: M017
Overnight Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	2cbd0966-4cf9-4271-bd53-6672b1ed2a99	2023-12-04	Warnings	Exact identifier application number: M017
Prolayed Lidocaine Male Genital Desensitizer	LIDOCAINE	ViaDerma Distribution, Inc.	9c5ad0d0-ca7a-4321-9334-f06f3f6be18f	2023-12-02	Warnings	Exact identifier application number: M017
Liberdol Topical Analgesic	METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)	ViaDerma Distribution, Inc	ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8	2023-12-01	Warnings	Exact identifier application number: M017
Prolayed	LIDOCAINE	MATRIX MIXOLOGY, INC	ae317876-adb1-6d13-e053-2995a90a74af	2023-12-01	Warnings	Exact identifier application number: M017
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Exact identifier application number: M017
Thera Plus Cool and Heat Pain Relieving Gel Menthol	MENTHOL	Fourstar Group USA, Inc.	0a225714-ccb1-4676-e063-6294a90aeeb2	2023-11-30	Warnings	Exact identifier application number: M017
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Exact identifier application number: M017
Ice Quake	MENTHOL	Southern Sales & Service, Inc.	7a05832f-49ac-4013-b240-4405501e45cd	2023-11-29	Warnings	Exact identifier application number: M017
ICE MUSCLE RUB Leon M.C	MENTHOL	Southern Sales & Service, Inc.	4efaf347-7406-4690-8005-e7cf2e3d4222	2023-11-29	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
646333	capsaicin 0.1 % Topical Cream	PSN	def8d341-06a7-0e9b-e053-2995a90a0ad6	4
646333	capsaicin 1 MG/ML Topical Cream	SCD	def8d341-06a7-0e9b-e053-2995a90a0ad6	4
646333	capsaicin 0.1 % Topical Cream	SY	def8d341-06a7-0e9b-e053-2995a90a0ad6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-103-02	69396010302	1 TUBE in 1 BOX (69396-103-02) / 60 g in 1 TUBE	1 tube	2022-05-14	0000-00-00	No	No	Current