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 35 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE CREAM 1%	Aldermed Inc.	4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d	2026-02-10	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	4a7f92d3-dd35-44a3-e063-6294a90ae004	2026-02-10	Warnings	Exact identifier application number: M017
NICOVITO HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e24fa-959e-79b4-e063-6294a90a8f68	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	2e7638c6-e1ce-4e2f-bd50-52fbce5a138e	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	2f272d12-7b34-430e-817e-1005f57ed9e9	2026-02-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA CORP	4303fd30-0d35-3671-e063-6394a90a2aee	2026-02-09	Warnings	Exact identifier application number: M017
Pain Relief Lidocaine	LIDOCAINE	Kroger Company	4098756e-3d9f-317a-e063-6394a90af04c	2026-02-09	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	4a698246-05a6-d01f-e063-6294a90a3401	2026-02-09	Warnings	Exact identifier application number: M017
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE	Ebanel Laboratories, Inc	41292d65-dabe-4bc3-872f-34a3912aa342	2026-02-09	Warnings	Exact identifier application number: M017
DERMFREE NEUROPATHY	ARNICA MONTANA 1X HPUS 7% NEUROPATHY	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c232d-5d29-2504-e063-6394a90ac9de	2026-02-08	Warnings	Exact identifier application number: M017
ASSIELF NUMBING Topical Anorectal	LIDOCAINE	Shenzhen Yuanbang International Logistics Co., Ltd	4a5cb477-57ef-2a1d-e063-6394a90ac9ed	2026-02-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieve Gel-Patch	PAIN RELIEVE GEL-PATCH	Henan Kangdi Medical Devices Co., Ltd	1e31b950-e990-e255-e063-6394a90a7d23	2026-02-07	Warnings	Exact identifier application number: M017
Herbal Knee Patch	HERBAL KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd	2a009059-b515-8214-e063-6294a90a4ed3	2026-02-07	Warnings	Exact identifier application number: M017
Flocean ANTI-ITCH	BENZOCAINE 5%ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a493911-a846-5aa0-e063-6294a90a65ac	2026-02-07	Warnings	Exact identifier application number: M017
daily solutions Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Garcoa, Inc.	4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6	2026-02-06	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Shenzhen Wankelai E-commerce Co., Ltd.	4a22562b-601e-97d7-e063-6394a90a5bca	2026-02-06	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ee64ad1e-78db-4553-a3cf-b539b770fa26	2026-02-06	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE 4%	Sportpharm LLC	1dd022b9-88ae-4737-88cc-fdb0ce0a83a3	2026-02-06	Warnings	Exact identifier application number: M017
Camphor plus Lidocaine Pain Relief	CAMPHOR, LIDOCAINE	Veridian Healthcare	4a2b73a8-c10c-85f9-e063-6294a90ac52c	2026-02-06	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Retail Business Services, LLC	073c72fe-3171-4a4f-913a-d1b9630a1af3	2026-02-06	Warnings, Adverse reactions	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