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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DZUL - LIDO CREME	LIDOCAINE HCL, MENTHOL	Caball Sales, Inc.	063387e4-a1b1-a467-e063-6294a90a6cbd	2026-01-08	Warnings	Exact identifier application number: M017
TOPICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	7f96e980-891e-743d-e053-2a91aa0aea5f	2026-01-08	Warnings	Exact identifier application number: M017
LUBRICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	9d7416b1-607d-34e0-e053-2a95a90aa3c3	2026-01-08	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	0a1aeff0-bade-457b-a0ac-099d646c0b2e	2026-01-08	Warnings	Exact identifier application number: M017
4% MENTHOL COLD THERAPY	MENTHOL	Universal Distribution Center LLC	66892993-a755-4584-b2a8-2e8d7ac70593	2026-01-08	Warnings	Exact identifier application number: M017
Private Label Antifungal Barrier Cream	2% MICONAZOLE NITRATE CREAM	Swiss-American CDMO, LLC	e74bddea-c1ac-4e4e-84bd-5a9defb85b2d	2026-01-08	Warnings	Exact identifier application number: M017
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	e1911279-85f7-4053-b6da-8f4e991347a2	2026-01-08	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE, MENTHOL	POMG LLC	1fa980fb-fc0e-fdd0-e063-6394a90adc13	2026-01-07	Warnings	Exact identifier application number: M017
Artridon Glucosamine	MENTHOL, METHYL SALICYLATE	Pharmadel LLC	73572156-4cce-0669-e053-2991aa0aaecc	2026-01-07	Warnings	Exact identifier application number: M017
HealthWise Cooling Pain Relief	MENTHOL	Veridian Healthcare	6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd	2026-01-07	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Exact identifier application number: M017
EARTHS CARE MUSCLE AND JOINT RUB	CAMPHOR	DLC Laboratories, Inc.	71e33e06-4dc3-4ead-a122-ff89d93a64de	2026-01-07	Warnings	Exact identifier application number: M017
Amour CBD	PAIN RELIEF CREAM	SVD Premium Products	95b45e79-b1e7-17b2-e053-2995a90a8836	2026-01-07	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle	METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	845a4ead-f9c0-4009-bcae-b17cd388439b	2026-01-07	Warnings	Exact identifier application number: M017
3X Medicated Toothache and Gum Gel	BENZOCAINE	Rite Aid	996f7989-17ce-5b28-e053-2995a90af8b8	2026-01-06	Warnings	Exact identifier application number: M017
QNTAMAX Muscle and Joint Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL	Qntamax LLC	6622b94c-824e-4e84-a8d8-b60bb0b866e2	2026-01-06	Warnings	Exact identifier application number: M017
Winco Muscle and Joint Pain Relief Gel 2oz	WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF	WINCO FOODS, LLC	47bedf4e-4036-cf43-e063-6394a90a91d6	2026-01-06	Warnings	Exact identifier application number: M017
Pain Relief Hot Patch	MENTHOL AND CAPSAICIN	Universal Distribution Center LLC	110bcb16-ef0b-4bc8-8877-173a0494e1ad	2026-01-06	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	4582b4e9-0c24-069d-e063-6394a90a6f4b	2026-01-05	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