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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbsure LIDOCAINE	LIDOCAINE 4%	Hambli Limited	43a65a12-ef2a-4608-e063-6394a90a82ea	2026-01-31	Warnings	Exact identifier application number: M017
Collajoint Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF GEL PATCH	Henan Enokon Medical Instrument Co., Ltd.	44e27e7f-992f-d194-e063-6294a90a94e4	2026-01-31	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT Patch	CAPSAICIN HEAT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac2045-2c07-af9a-e063-6294a90a052a	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac6a7b-25d3-6dc4-e063-6394a90a99b6	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49aca763-be2a-cf38-e063-6294a90a092e	2026-01-31	Warnings	Exact identifier application number: M017
PAIN RELIEF HOT Patch	PAIN RELIEF HOT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ad128a-0f4c-085a-e063-6294a90ac9bb	2026-01-31	Warnings	Exact identifier application number: M017
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	3557d2e9-714a-4066-aa73-ea9e3363e574	2026-01-30	Warnings	Exact identifier application number: M017
Alveora HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4996f96a-898e-de01-e063-6394a90a3907	2026-01-30	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Rite Aid Corporation	b67af0c7-1ae8-4494-bb0e-d7f66ebca352	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS	CAPSAICIN	OL PHARMA TECH,LLC	48fdf9dc-05df-866d-e063-6294a90ae03a	2026-01-30	Warnings	Exact identifier application number: M017
ROCKTAPE GO Kinesiology Tape and Analgesic	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	b779c7d8-dbe6-472f-9282-6cced25cfd2e	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	de5f7add-1f2b-438a-ac17-753ebb53e697	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll-On	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	5a2d9c3a-67fc-4c1a-b1e8-62a93880397a	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Dr. Collado	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A	c0dad2db-7c96-49b8-a451-bf8cfa7f798b	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	3121c7f7-d7e5-4ca9-9057-03edf9c94c56	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A.	87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d	2026-01-29	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone Cream Plus	HYDROCORTISONE	Rooftop Consumer Health, Inc.	fe334cae-e019-4397-8498-df3c923ae8b5	2026-01-29	Warnings	Exact identifier application number: M017
Red Oil Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL, PHENOL	The Red Oil Company Inc	1e36579a-72da-46ba-ac72-5960a11c0880	2026-01-29	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM, MENTHOL	NATURES FORMULAE HEALTH PRODUCTS LTD.	498a5e2a-4de0-561c-e063-6394a90ac05c	2026-01-29	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET POTENT PAIN RELIEF	45c76956-db3f-3e84-e063-6394a90adce1	2026-01-29	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