Mag 5 PT Cooling Formula Recovery Cream

Product NDC: 76348-510
11-digit product format: 763480510
Labeler code: 76348
Product ID: 76348-510_43e53829-1764-6b61-e063-6394a90a53de
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: RENU LABORATORIES, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-19
Substance: MENTHOL
Active strength: 22.7 g/454g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76348-510-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76348-510-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76348-510-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-510-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-510-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-510-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-510-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Mag 5 PT Cooling Formula Recovery Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	22.7 g/454g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a45cde67-64ec-643b-e053-2a95a90a10b6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
4d7a96d5-8256-4268-9a6c-25ea66d321fe	Product name	1	20180814
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-510-16	2025-03-25	C162847	48780-1	2cef2736-6d23-d83d-e063-dadaa90ab31f	MAG 5 PT COOLING FORMULA RECOVERY CREAM
76348-510-16	2025-01-30	C162847	48780-1	2cef2736-6d23-d83d-e063-dadaa90ab31f	MAG 5 PT COOLING FORMULA RECOVERY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76348-510-04	Mag 5 PT Cooling Formula Recovery Cream	112 g in 1 JAR	CREAM	112	8
76348-510-05	Mag 5 PT Cooling Formula Recovery Cream	1 in 1 BOX	CREAM	1	8
76348-510-16	Mag 5 PT Cooling Formula Recovery Cream	454 g in 1 JAR	CREAM	454	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-510	MAG 5 PT COOLING FORMULA RECOVERY CREAM (MENTHOL) CREAM [RENU LABORATORIES, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250330_a45cde67-64ec-643b-e053-2a95a90a10b6.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 140 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	Warnings	Exact identifier application number: M017
XRay Pain Relief	MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE	Genomma Lab USA	5244ddee-fd9e-4df3-8fb3-b16aa321a316	2023-12-27	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Pharma Nobis, LLC	e42fbe63-b01c-4f85-e053-2a95a90a5143	2023-12-26	Warnings	Exact identifier application number: M017
Equate Calaspray	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Walmart Inc	027ed5ab-05ec-569f-e063-6394a90abbc3	2023-12-26	Warnings	Exact identifier application number: M017
EXTERNAL ANALGESIC	CAMPHOR, CAPSICUM, MENTHOL	Hmong 21	3b6155a5-51aa-2780-e054-00144ff8d46c	2023-12-26	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76348-510-04	76348051004	112 g in 1 JAR	112 g				Historical
76348-510-05	76348051005	1 JAR in 1 BOX (76348-510-05) / 112 g in 1 JAR (76348-510-04)	1 jar	2019-03-19	No	No	Current
76348-510-16	76348051016	454 g in 1 JAR (76348-510-16)	454 g	2019-03-19	No	No	Current