Ortho-Nesic With Capsaicin

Product NDC: 65373-401
11-digit product format: 653730401
Labeler code: 65373
Product ID: 65373-401_37672821-f011-4436-be93-a9c8832e26bf
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1995-01-01
Marketing end: 0000-00-00
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: 4 g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65373-401		I	Inactivated by FDA	2026-09-09
excluded package	package	65373-401	65373-401-01	I	Inactivated by FDA	2026-09-09
excluded package	package	65373-401	65373-401-02	I	Inactivated by FDA	2026-09-09
excluded package	package	65373-401	65373-401-03	I	Inactivated by FDA	2026-09-09
excluded package	package	65373-401	65373-401-04	I	Inactivated by FDA	2026-09-09

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 2 · 110 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 package	package	65373-401-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65373-401-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65373-401-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65373-401-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65373-401-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65373-401-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65373-401-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65373-401-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65373-401-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65373-401-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65373-401-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65373-401-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65373-401-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65373-401-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65373-401-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65373-401-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65373-401-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65373-401-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65373-401-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65373-401-02	`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 package	package	65373-401-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65373-401-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65373-401-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65373-401-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65373-401-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65373-401-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65373-401-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65373-401-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65373-401-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65373-401-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65373-401-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65373-401-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
65373-401-01	b000b58f-a407-411e-8d35-8459fe1b9297
65373-401-02	b000b58f-a407-411e-8d35-8459fe1b9297
65373-401-03	b000b58f-a407-411e-8d35-8459fe1b9297
65373-401-04	b000b58f-a407-411e-8d35-8459fe1b9297

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65373-401-01	Ortho-Nesic With Capsaicin	170 g in 1 TUBE	GEL	170	2
65373-401-02	Ortho-Nesic With Capsaicin	907 g in 1 BOTTLE, PUMP	GEL	907	2
65373-401-03	Ortho-Nesic With Capsaicin	3629 g in 1 BOTTLE, PUMP	GEL	3629	2
65373-401-04	Ortho-Nesic With Capsaicin	85 g in 1 TUBE, WITH APPLICATOR	GEL	85	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
CAPSAICIN	INACTIVE INGREDIENT	S07O44R1ZM	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65373-401	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	2	Legacy NDC, 4 package rows	20110126_b000b58f-a407-411e-8d35-8459fe1b9297.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416207	camphor 0.2 % / menthol 3.5 % Topical Gel	PSN	b000b58f-a407-411e-8d35-8459fe1b9297	2
1087242	Ortho-Nesic 0.2 % / 3.5 % Topical Gel	PSN	b000b58f-a407-411e-8d35-8459fe1b9297	2
1087242	camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical Gel [Ortho-Nesic]	SBD	b000b58f-a407-411e-8d35-8459fe1b9297	2
416207	camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical Gel	SCD	b000b58f-a407-411e-8d35-8459fe1b9297	2
416207	camphor 0.2 % / menthol 3.5 % Topical Gel	SY	b000b58f-a407-411e-8d35-8459fe1b9297	2
1087242	Ortho-Nesic (camphor 0.002 MG/MG / menthol 0.035 MG/MG) Topical Gel	SY	b000b58f-a407-411e-8d35-8459fe1b9297	2
1087242	Ortho-Nesic (camphor 0.2 % / menthol 3.5 % ) Topical Gel	SY	b000b58f-a407-411e-8d35-8459fe1b9297	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65373-401-01	65373040101	170 g in 1 TUBE	170 g	Historical
65373-401-02	65373040102	907 g in 1 BOTTLE, PUMP	907 g	Historical
65373-401-03	65373040103	3629 g in 1 BOTTLE, PUMP	3629 g	Historical
65373-401-04	65373040104	85 g in 1 TUBE, WITH APPLICATOR	85 g	Historical