Hot Spot

Product NDC: 65121-010
11-digit product format: 651210010
Labeler code: 65121
Product ID: 65121-010_42f16670-ee65-4cf8-9aa2-2a7bb87a6388
Type: HUMAN OTC DRUG
Nonproprietary name: capsaicin
Dosage form: GEL
Route: TOPICAL
Labeler: Pure Source
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-08-24
Marketing end: 0000-00-00
Substance: CAPSAICIN
Active strength: 1 mL/90mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65121-010		I	Inactivated by FDA	2026-10-05
excluded product	product	65121-010		I	Inactivated by FDA	2026-10-05
excluded product	product	65121-010		I	Inactivated by FDA	2026-10-05
excluded package	package	65121-010	65121-010-08	I	Inactivated by FDA	2026-10-05
excluded package	package	65121-010	65121-010-03	I	Inactivated by FDA	2026-10-05
excluded package	package	65121-010	65121-010-32	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 132 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65121-010-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65121-010-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65121-010-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65121-010-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65121-010-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65121-010-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65121-010-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65121-010-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65121-010-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65121-010-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65121-010-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65121-010-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65121-010-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65121-010-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65121-010-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65121-010-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65121-010-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65121-010-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65121-010-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65121-010-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65121-010-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65121-010-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65121-010-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65121-010-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65121-010-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65121-010-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65121-010-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65121-010-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65121-010-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65121-010-08	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65121-010-03	2019-10-29	C162847	48780-1	960f7f55-d862-8e05-e053-dbdaa90a074a	Hot Spot Point Relief Pain relieving gel - 3 oz.
65121-010-08	2019-10-29	C162847	48780-1	960f7f55-cfad-8e05-e053-dbdaa90a074a	Hot Spot Point Relief Pain relieving gel - 8 oz.
65121-010-32	2019-10-29	C162847	48780-1	960f7f55-c812-8e05-e053-dbdaa90a074a	Hot Spot Point Relief Pain relieving gel - 32 oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65121-010-03	Hot SpotPoint Relief	90 mL in 1 TUBE	GEL	90	3
65121-010-08	Hot SpotPoint Relief	240 mL in 1 TUBE	GEL	240	3
65121-010-32	Hot SpotPoint Relief	960 mL in 1 BOTTLE, PUMP	GEL	960	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
water	INACTIVE INGREDIENT	059QF0KO0R	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
water	INACTIVE INGREDIENT	059QF0KO0R	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3
water	INACTIVE INGREDIENT	059QF0KO0R	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65121-010	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3	Legacy NDC, 1 package rows	20101104_e9b7a7b0-21ef-4a73-91de-5f78741acb74.zip
65121-010	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3	Legacy NDC, 1 package rows	20101022_02534f4f-6041-46e2-99a2-a3caef5c4e40.zip
65121-010	HOT SPOT POINT RELIEF (CAPSAICIN) GEL [PURE SOURCE]	3	Legacy NDC, 1 package rows	20101104_0d00340c-4034-4fdf-9c2f-0bc6086a08d2.zip

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
1043201	capsaicin 0.06 % Topical Gel	PSN	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043201	capsaicin 0.06 % Topical Gel	PSN	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043201	capsaicin 0.06 % Topical Gel	PSN	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043205	HotSpot POINT RELIEF 0.06 % Topical Gel	PSN	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043205	HotSpot POINT RELIEF 0.06 % Topical Gel	PSN	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043205	HotSpot POINT RELIEF 0.06 % Topical Gel	PSN	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043205	capsaicin 0.0006 MG/MG Topical Gel [Hot Spot]	SBD	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043205	capsaicin 0.0006 MG/MG Topical Gel [Hot Spot]	SBD	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043205	capsaicin 0.0006 MG/MG Topical Gel [Hot Spot]	SBD	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043201	capsaicin 0.0006 MG/MG Topical Gel	SCD	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043201	capsaicin 0.0006 MG/MG Topical Gel	SCD	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043201	capsaicin 0.0006 MG/MG Topical Gel	SCD	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043201	capsaicin 0.06 % Topical Gel	SY	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043201	capsaicin 0.06 % Topical Gel	SY	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043201	capsaicin 0.06 % Topical Gel	SY	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043205	Hot Spot 0.0006 MG/MG Topical Gel	SY	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043205	Hot Spot 0.0006 MG/MG Topical Gel	SY	02534f4f-6041-46e2-99a2-a3caef5c4e40	3
1043205	Hot Spot 0.0006 MG/MG Topical Gel	SY	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043205	Hot Spot Point Relief 0.06 % Topical Gel	SY	0d00340c-4034-4fdf-9c2f-0bc6086a08d2	3
1043205	Hot Spot Point Relief 0.06 % Topical Gel	SY	e9b7a7b0-21ef-4a73-91de-5f78741acb74	3
1043205	Hot Spot Point Relief 0.06 % Topical Gel	SY	02534f4f-6041-46e2-99a2-a3caef5c4e40	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65121-010-03	65121001003	90 mL in 1 TUBE	90 ml	Historical
65121-010-08	65121001008	240 mL in 1 TUBE	240 ml	Historical
65121-010-32	65121001032	960 mL in 1 BOTTLE, PUMP	960 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hot Spot Point Relief Pain relieving gel - 3 oz.	Pure Source	2010-08-30	HUMAN OTC DRUG LABEL	3
Hot Spot Point Relief Pain relieving gel - 8 oz.	Pure Source	2010-08-30	HUMAN OTC DRUG LABEL	3
Hot Spot Point Relief Pain relieving gel - 32 oz.	Pure Source	2010-08-30	HUMAN OTC DRUG LABEL	3