MAG 5 PT WARMING FORMULA

Product NDC: 76348-511
11-digit product format: 763480511
Labeler code: 76348
Product ID: 76348-511_574988ea-50c0-bcb0-e063-6294a90ad749
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: 5.6 g/112g
NDC exclude flag: No
Listing certified through: 2027-12-31
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	76348-511-05	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	76348-511-05	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	76348-511-05	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	76348-511-05	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	76348-511-05	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	76348-511-05	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	76348-511-05	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 WARMING FORMULA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.6 g/112g

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
a499ac9b-0e8e-e23f-e053-2a95a90abe9a	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#

Effective, Related label table
Effective	Related label
2025-03-27	MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-03-27	MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-01-30	MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-01-30	MAG 5 PT WARMING FORMULA RECOVERY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-511-04	MAG 5 PT WARMING FORMULA	112 g in 1 JAR	CREAM	112		10
76348-511-05	MAG 5 PT WARMING FORMULA	1 in 1 BOX	CREAM	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-511	MAG 5 PT WARMING FORMULA (MENTHOL) CREAM [RENU LABORATORIES, LLC]	9	Current NDC, 2 package rows	20250330_a499ac9b-0e8e-e23f-e053-2a95a90abe9a.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 13 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Ice Methol Pain Relief	MENTHOL 10.5 %	Sunflora Inc	6ddd9e97-f717-4d5a-9658-26449a3cc831	2026-07-02	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	AmerisourceBergen Drug Corporation	7d898e33-ded7-c9b9-e053-2a91aa0adf7c	2026-07-01	Warnings	Exact identifier application number: M017
Desert Harvest Releveum with Lidocaine	LIDOCAINE HYDROCHLORIDE	Desert Harvest, Inc	9ad514ab-a6bd-4564-8ba3-0149032ebf36	2026-07-01	Warnings	Exact identifier application number: M017
CVS No Mess Cortisone	HYDROCORTISONE	Natural Essentials, Inc.	558c94ec-95f1-eb98-e063-6394a90a1e72	2026-07-01	Warnings	Exact identifier application number: M017
MUSCLE EASE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	03fff4bf-04ed-49a6-b40f-4d98c2b42f69	2026-07-01	Warnings	Exact identifier application number: M017
OrthoNesic Pain Relieving Gel	MENTHOL, CAMPHOR	Blaine Labs Inc.	122f60c2-f8df-4625-8bb8-a2244a261b5d	2026-07-01	Warnings	Exact identifier application number: M017
Desert Harvest RELEVEUM	LIDOCAINE	Desert Harvest Inc.	5d9010ec-d482-44ff-ba27-3bfec5a241c6	2026-06-30	Warnings	Exact identifier application number: M017
Promescent	LIDICAINE	Absorption	5b508238-3be7-4b0d-bf35-51de79f58f55	2026-06-30	Warnings	Exact identifier application number: M017
Lidovyx	LIDOCAINE 4%	V2 Pharma LLC	4465eb60-a617-4608-9504-8b3b4c64f49e	2026-06-30	Warnings	Exact identifier application number: M017
Dr.Johnes Lidocaine 4% Topical Analgesic Cream	LIDOCAINE HCL,MENTHOL	Dr.Johnes LLC	6144708d-4b0f-4f0d-88e3-6925ba2d004d	2026-06-29	Warnings	Exact identifier application number: M017
Dr Sabharwals	METHYL SALICYLATE 10% GEL PATCH	Dr. Sabharwal's Wound Care	4a7790bb-25cb-72b8-e063-6294a90a6b9c	2026-06-29	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier application number: M017
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Unishield	f86f7446-b741-9f40-e053-6394a90a4422	2026-06-29	Warnings	Exact identifier application number: M017
MQ Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5560cdab-cee8-f6ec-e063-6294a90ad024	2026-06-29	Warnings	Exact identifier application number: M017
GNP Lidocaine Maximum Strength	LIDOCAINE HCL	AMERISOURCE BERGEN	9f559c20-c9ac-e480-e053-2a95a90a8fce	2026-06-29	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	5553385d-c1e6-1242-e063-6394a90aa5a7	2026-06-28	Warnings	Exact identifier application number: M017
MOROVAN	LIDOCAINE	HONG KONG UNORDERED TRADING CO., LIMITED	550c8d2d-e0d7-1531-e063-6394a90a374d	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas, LLC	5517ee5f-1c51-cfd6-e063-6294a90af56f	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas LLC	55188ede-68cd-fcc6-e063-6394a90a5c58	2026-06-25	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	NuCare Pharmaceuticals, Inc.	54f07a23-213f-ca46-e063-6394a90a0034	2026-06-24	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
76348-511-04	76348051104	112 g in 1 JAR	112 g				Historical
76348-511-05	76348051105	1 JAR in 1 BOX (76348-511-05) / 112 g in 1 JAR (76348-511-04)	1 jar	2019-03-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAG 5 PT WARMING FORMULA RECOVERY CREAM	RENU LABORATORIES, LLC	2026-07-23	HUMAN OTC DRUG LABEL	11