EB301AP PAIN RELIEF

Product NDC: 53304-0301
11-digit product format: 533040301
Labeler code: 53304
Product ID: 53304-0301_5a7a2a80-df3b-4501-abbe-62a5d062134f
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: SPRAY
Route: TOPICAL
Labeler: EMINENCE BIOTECH CORPORATION LIMITED
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-01
Marketing end: 0000-00-00
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 1000 mg/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53304-0301		I	Inactivated by FDA	2026-08-17
excluded package	package	53304-0301	53304-0301-1	I	Inactivated by FDA	2026-08-17
excluded package	package	53304-0301	53304-0301-3	I	Inactivated by FDA	2026-08-17

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 1 · 45 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	53304-0301-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53304-0301-1	`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	53304-0301-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53304-0301-1	`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	53304-0301-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53304-0301-1	`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	53304-0301-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53304-0301-1	`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	53304-0301-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53304-0301-1	`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	53304-0301-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53304-0301-1	`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	53304-0301-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53304-0301-1	`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	53304-0301-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53304-0301-1	`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	53304-0301-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53304-0301-1	`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	53304-0301-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53304-0301-1	`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	53304-0301-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53304-0301-1	`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	53304-0301-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53304-0301-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53304-0301-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53304-0301-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53304-0301-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53304-0301-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53304-0301-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53304-0301-1	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53304-0301-1	2023-01-30	C162847	48780-1	f386c649-c8db-0266-e053-dadaa90a7c1a	EB301AP PAIN RELIEF
53304-0301-3	2023-01-30	C162847	48780-1	f386c649-c8db-0266-e053-dadaa90a7c1a	EB301AP PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53304-0301-1	EB301AP PAIN RELIEF	1 in 1 BOX	SPRAY	1	3
53304-0301-1	EB301AP PAIN RELIEF	100 mL in 1 BOTTLE, SPRAY	SPRAY	100	3
53304-0301-3	EB301AP PAIN RELIEF	1 in 1 BOX	SPRAY	1	3
53304-0301-3	EB301AP PAIN RELIEF	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
EUPHORBIA HIRTA	INACTIVE INGREDIENT	L13YF113GN	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
EUPHORBIA THYMIFOLIA WHOLE	INACTIVE INGREDIENT	D56Y3D2OTL	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
GAULTHERIA PROCUMBENS LEAF	INACTIVE INGREDIENT	2125M16OWN	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
PORK SIDE BACON, CURED FAT	INACTIVE INGREDIENT	6E710H379S	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53304-0301	EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]	3	Legacy NDC, 4 package rows	20180321_3a5fe77f-c36a-41c0-ba86-0664b942e144.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1371206	menthol 1 % Topical Spray	PSN	3a5fe77f-c36a-41c0-ba86-0664b942e144	3
1371206	menthol 10 MG/ML Topical Spray	SCD	3a5fe77f-c36a-41c0-ba86-0664b942e144	3
1371206	menthol 1 % Topical Spray	SY	3a5fe77f-c36a-41c0-ba86-0664b942e144	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53304-0301-1	53304030101	1 BOTTLE, SPRAY in 1 BOX (53304-0301-1) > 100 mL in 1 BOTTLE, SPRAY	2013-03-01	0000-00-00	No	No	Current
53304-0301-3	53304030103	1 BOTTLE, SPRAY in 1 BOX (53304-0301-3) > 15 mL in 1 BOTTLE, SPRAY	2013-03-01	0000-00-00	No	No	Current