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 80 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	27679d31-a5f3-417b-b0c5-5f6b001ecff9	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	52fff03e-eba2-4604-a71c-2522468f627b	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de210c3a-c24e-cefd-e053-2a95a90a93ff	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	799751f3-726a-42de-934e-dbc3cd1cb8b8	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de0c9a73-dbc0-599e-e053-2a95a90a7986	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	90334420-5f81-4284-9a57-42e134ce362f	2025-09-02	Warnings	Exact identifier application number: M017
KNEE PAIN RELIRF Patch	CAMPHOR, MENTHOL	Shenzhen Finona Information Technology Co., Ltd	3db971ef-d7fa-0171-e063-6294a90aa58b	2025-09-01	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Creme	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	300ac57e-844a-4840-b285-41ff5518e6b6	2025-08-29	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Gel	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	30b85890-e72d-4af7-bda9-e7744abc92af	2025-08-29	Warnings	Exact identifier application number: M017
Sumifun Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3d7dc8cc-0680-d94d-e063-6394a90ac8e8	2025-08-29	Warnings	Exact identifier application number: M017
TKTALKER NUMBING	NUMBING	Shenzhen Shandian Jingling Technology Co., Ltd.	3d7e6757-f183-2a68-e063-6294a90ae4ca	2025-08-29	Warnings	Exact identifier application number: M017
PBZ OTC	TRIPELENNAMINE HCL 1%	Kingsway Pharmaceuticals dba NFI, LLC	12f72d74-018f-4bc6-acd4-175ca3af4c6d	2025-08-29	Warnings	Exact identifier application number: M017
else.	LIDOCAINE	Else Co.	3d6c7b10-ed03-bbde-e063-6294a90ae92f	2025-08-28	Warnings	Exact identifier application number: M017
Mountain Ice Pain Relief	MENTHOL	Mountainside Medical Equipment, Inc.	c79fdd91-16f4-4ae0-bee4-d37c05ed2074	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise 4% Lidocaine Cream 2.7 oz	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	f39eb3d0-e153-4f50-85b1-ad5c677d176c	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise Overnight Menthol Patch	MENTHOL	Veridian Healthcare	6379f50d-2878-46ca-8acb-71c4554585e9	2025-08-28	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	119bab58-f129-4ff0-8d81-9c6a7b508dd6	2025-08-28	Warnings	Exact identifier application number: M017
Anti Itch Maximum Relief	PRAMOXINE HYDROCHLORIDE AND MENTHOL	Natureplex LLC	75de3d5e-ecbe-4d04-a39d-792200e6ee32	2025-08-28	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	3d5718f3-c175-6b64-e063-6394a90aa6f1	2025-08-27	Warnings	Exact identifier application number: M017
ARCTIC HEAT	MENTHOL, METHYL SALICYLATE	Renu Laboratories, LLC	402df5c1-b8cb-17a2-e054-00144ff8d46c	2025-08-27	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