Mr Dudleys Topical Pain Relief

Product NDC: 58484-100
11-digit product format: 584840100
Labeler code: 58484
Product ID: 58484-100_e912b891-a457-4224-8a5b-7b7cb2b9a268
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: DUDLEY WELLNESS COMPANY INC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-05-13
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 3 g/100g
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58484-100		I	Inactivated by FDA	2026-10-15
excluded package	package	58484-100	58484-100-01	I	Inactivated by FDA	2026-10-15
excluded package	package	58484-100	58484-100-05	I	Inactivated by FDA	2026-10-15
excluded package	package	58484-100	58484-100-20	I	Inactivated by FDA	2026-10-15
excluded package	package	58484-100	58484-100-45	I	Inactivated by FDA	2026-10-15

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	58484-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58484-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58484-100-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58484-100-45	`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	58484-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58484-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58484-100-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58484-100-45	`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	58484-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58484-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58484-100-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58484-100-45	`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	58484-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58484-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58484-100-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58484-100-45	`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	58484-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58484-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58484-100-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58484-100-45	`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	58484-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58484-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58484-100-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58484-100-45	`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	58484-100-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58484-100-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58484-100-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58484-100-45	`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	58484-100-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58484-100-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58484-100-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58484-100-45	`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	58484-100-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58484-100-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58484-100-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58484-100-45	`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	58484-100-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58484-100-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58484-100-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58484-100-45	`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	58484-100-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58484-100-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58484-100-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58484-100-45	`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	58484-100-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58484-100-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58484-100-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58484-100-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
58484-100-01	Drug Facts
58484-100-05	Drug Facts
58484-100-20	Drug Facts
58484-100-45	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58484-100-01	Mr Dudleys Topical Pain Relief	.2 g in 1 BOTTLE	CREAM	.2	1
58484-100-05	Mr Dudleys Topical Pain Relief	1.4 g in 1 BOTTLE	CREAM	1.4	1
58484-100-20	Mr Dudleys Topical Pain Relief	57 g in 1 BOTTLE	CREAM	57	1
58484-100-45	Mr Dudleys Topical Pain Relief	128 g in 1 BOTTLE	CREAM	128	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
4-ALLYL-2,6-DIMETHOXYPHENOL	INACTIVE INGREDIENT	8VF00YWP89	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
ACRYLAMIDE	INACTIVE INGREDIENT	20R035KLCI	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
METHYL EUGENOL	INACTIVE INGREDIENT	29T9VA6R7M	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
METHYL ISOEUGENOL	INACTIVE INGREDIENT	46RN7Q97DE	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
NUTMEG OIL	INACTIVE INGREDIENT	Z1CLM48948	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58484-100	MR DUDLEYS TOPICAL PAIN RELIEF (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1	Legacy NDC, 4 package rows	20130514_ec239064-987a-4341-acb6-b4de3a6e76be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1291226	menthol 2.5 % Topical Cream	PSN	ec239064-987a-4341-acb6-b4de3a6e76be	1
1291226	menthol 25 MG/ML Topical Cream	SCD	ec239064-987a-4341-acb6-b4de3a6e76be	1
1291226	menthol 2.5 % Topical Cream	SY	ec239064-987a-4341-acb6-b4de3a6e76be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58484-100-01	58484010001	.2 g in 1 BOTTLE		Historical
58484-100-05	58484010005	1.4 g in 1 BOTTLE	1.4 g	Historical
58484-100-20	58484010020	57 g in 1 BOTTLE	57 g	Historical
58484-100-45	58484010045	128 g in 1 BOTTLE	128 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	DUDLEY WELLNESS COMPANY INC \| DUDLEY MANUFACTURING LLC.	2013-05-10	HUMAN OTC DRUG LABEL	1