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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Advanced Rx of Tennessee, LLC	44840250-2112-6ef4-e063-6394a90acdcc	2026-06-12	Warnings	Exact identifier application number: M017
DRAWYUM Pain Relief Gel-Patch	LIDOCAINE 4% PAIN RELIEF GEL-PATCH	Jiangxi Yudexi Pharmaceutical Co., LTD	497e6e18-ba46-0001-e063-6294a90af026	2026-06-12	Warnings	Exact identifier application number: M017
NATUHEAL JOINT BACK PAIN RELIEF	ARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4c923afa-4d1e-0776-e063-6294a90a2f54	2026-06-12	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	Aldermed Inc.	4a7b532e-b292-b595-e063-6394a90acc9c	2026-06-12	Warnings	Exact identifier application number: M017
MG PLUS MENTHOL	MENTHOL	RENU LABORATORIES, LLC	53737365-b985-3800-e063-6294a90a37f2	2026-06-11	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	7c78d980-fc94-498c-aec5-464c0c76c8f4	2026-06-11	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a47f1ed-d8cf-3b0b-e063-6394a90a932a	2026-06-11	Warnings	Exact identifier application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride	PRAMOXINE HYDROCHLORIDE	The Honey Pot Company LLC	81ab7fa7-d9b0-49dc-9782-02f37e588c5e	2026-06-10	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Cream with Lidocaine	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	ef176d33-10b9-ddb2-e053-2995a90a76e3	2026-06-10	Warnings	Exact identifier application number: M017
Warm Patch Tong Gu Huo Luo Gao	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	6906c4a0-1557-45e3-b915-80e4dd652ee7	2026-06-10	Warnings	Exact identifier application number: M017
LidoMedix	LIDOCAINE, MENTHOL, CAMPHOR	Absolute Therapeutics, LLC	53d504ef-eea3-6a47-e063-6394a90a1f65	2026-06-09	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e51047da-8e17-4dd7-be3c-54820a7485f2	2026-06-09	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate Wash	PRAMOXINE HYDROCHLORIDE	Rida LLC	09964550-049c-4c3b-817d-37e660c2e45c	2026-06-08	Warnings	Exact identifier application number: M017
Quality Choice Lidocaine Pain Relief Patch	LIDOCAINE	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	526abe69-4bbc-6e73-e063-6394a90ad25d	2026-06-08	Warnings	Exact identifier application number: M017
Dcsily Numbing Cream	LIDOCAINE	Shenzhen Xinxin Yunhai Technology Co., Ltd.	53cab09c-6d5d-471e-e063-6294a90aa977	2026-06-08	Warnings	Exact identifier application number: M017
Easment 0.1% Capsaicin cream for sensitive skin	CAPSAICIN 0.1%	Easment LLC	537e0106-9e1c-66b8-e063-6294a90ac538	2026-06-05	Warnings	Exact identifier application number: M017
Maximum Strength Pain Relief	MENTHOL CREAM	OWELL NATURALS LLC	5388f2c5-8cfd-a601-e063-6294a90a2e5f	2026-06-04	Warnings	Exact identifier application number: M017
MG PLUS ROLL ON	MENTHOL ROLL ON	RENU LABORATORIES, LLC	535dc42f-38c7-2afc-e063-6294a90ae23d	2026-06-03	Warnings	Exact identifier application number: M017
OP First Aid Series Insect Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co.,Ltd.	b43af183-834a-0f64-e053-2995a90a3218	2026-06-03	Warnings	Exact identifier application number: M017
PURE PRIMAL DELAY	LIDOCAINE HCL	Prodigy Media Inc	1ddab664-7c44-452f-854f-e386cd69505e	2026-06-03	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