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 36 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Soothing Lidocaine Pain Relief	LIDOCAINE HCI 0.5%	Veridian Healthcare	4a2ec73e-7332-6f13-e063-6294a90a8506	2026-02-06	Warnings	Exact identifier application number: M017
5 Elementum Delay Wipes	BENZOCAINE DELAY WIPES	MSVenturesGroup O	440539b0-612b-3b41-e063-6294a90a1ddd	2026-02-05	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4a156400-7001-d00d-e063-6294a90aa714	2026-02-05	Warnings	Exact identifier application number: M017
burnrelief	LIDOCAINE HCL	Publix Super Markets, Inc.	9660f5e1-d39e-4f86-bf96-dff0f3bb729d	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Publix Super Markets, Inc.	fe442f1e-7045-481a-a501-d629bf568dfb	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M017
Care Lix Pain Relief	SALICYLIC ACID	ACQUIRED B SCALE LLC	65dffffd-ede1-45e2-aa91-bdd5df2df6a6	2026-02-05	Warnings	Exact identifier application number: M017
2.5% Menthol PAIN RELIEF	MENTHOL	Nantong Health & Beyond Hygienic Products Inc.	8075ba60-772c-4d1a-8584-722bb3e539be	2026-02-05	Warnings	Exact identifier application number: M017
4% Menthol PAIN RELIEF	MENTHOL	Nantong Health & Beyond Hygienic Products Inc.	51ce716e-b9f3-4e64-8c8e-17520d40f192	2026-02-05	Warnings	Exact identifier application number: M017
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	2b58058a-f350-4029-b039-117caf1c0373	2026-02-05	Warnings	Exact identifier application number: M017
4% MENTHOL COLD THERAPY	MENTHOL	Nantong Health & Beyond Hygienic Products Inc.	7acc7282-ef4f-41ec-b51d-a88dfed79bd7	2026-02-05	Warnings	Exact identifier application number: M017
Cooling Gel	PAIN RELIEF COOLING GEL	NeilMed Pharmaceuticals Inc.	49fb637b-ecc5-1f9b-e063-6294a90ab41a	2026-02-04	Warnings	Exact identifier application number: M017
Medicaine Sting and Bite	BENZOCAINE	Dynarex Corporation	b721607e-e36b-4691-a824-c8f520bd6386	2026-02-04	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	CHEMCO CORPORATION	4a05f02e-e882-2cb2-e063-6394a90ad328	2026-02-04	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4a065965-43bd-e0e3-e063-6294a90ad76a	2026-02-04	Warnings	Exact identifier application number: M017
Menthol plus Camphor Pain Relief	MENTHOL, CAMPHOR	Veridian Healthcare	4a0969d3-1f06-3ba7-e063-6294a90a8627	2026-02-04	Warnings	Exact identifier application number: M017
Relief Flex	MENTHOL	Beone Co., Ltd.	49e6f0ef-78fb-26fe-e063-6294a90a6655	2026-02-03	Warnings	Exact identifier application number: M017
Antiseptic Mouth Rinse	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Demoulas Super Markets, Inc	87263c47-0977-487f-a348-8b9e2ee69446	2026-02-03	Warnings	Exact identifier application number: M017
NATURULZ ULTIMATE HEALING	CAPSAICIN	I SHAY COSMETICS INC	436eac74-d07f-d718-e063-6394a90a8660	2026-02-03	Warnings	Exact identifier application number: M017
TheraCare Muscle and Join Pain Relieving Cream	MENTHOL, METHYL SALICYLATE	Veridian Healthcare	18f9829e-c5f9-4253-e063-6394a90a70c6	2026-02-03	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	8b8cdb26-8e8f-4e95-9d83-d685c90afe01	2026-02-02	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