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 15 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tiger Balm Pain Relieving Cool	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	41590ba1-32bb-4352-97ba-d6a3cc9d0546	2026-06-15	Warnings	Exact identifier application number: M017
HIGH POTENCY PAIN RELIEF	CAPSAICIN	Xiamen Weisiqi Technology Co., Ltd.	543949a4-86ed-3734-e063-6394a90a24f2	2026-06-14	Warnings	Exact identifier application number: M017
Natucure HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	49e402ed-d314-e896-e063-6294a90a826b	2026-06-14	Warnings	Exact identifier application number: M017
Nieapf NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e7534f-bccf-4ef4-e063-6294a90aeb7f	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	HEALMUSZ NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49976ff7-49a4-e4ed-e063-6294a90a3f78	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ HEMORRHOID FISSURE	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSURE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a342ac0-6a8d-3408-e063-6394a90a9a10	2026-06-14	Warnings	Exact identifier application number: M017
BOTASUN QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	4fa00db9-def5-dcfa-e063-6394a90ac8c2	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4cbb7df5-5771-ce4b-e063-6294a90aab80	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ ECZEMA	HYDROCORTISONE 1% ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	511e54e0-2abe-fb76-e063-6294a90ada68	2026-06-14	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-ItchCream	HYDROCORTISONE	Acme United Corporation	5425fc2b-4f25-3e64-e063-6394a90aff49	2026-06-13	Warnings	Exact identifier application number: M017
Icy Hot Pain Relieving Balm	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	40c8c02f-fa5f-4e80-81a0-48271fa6f94b	2026-06-12	Warnings	Exact identifier application number: M017
Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Advanced Rx of Tennessee, LLC	44840250-2112-6ef4-e063-6394a90acdcc	2026-06-12	Warnings	Exact identifier application number: M017
DRAWYUM Pain Relief Gel-Patch	LIDOCAINE 4% PAIN RELIEF GEL-PATCH	Jiangxi Yudexi Pharmaceutical Co., LTD	497e6e18-ba46-0001-e063-6294a90af026	2026-06-12	Warnings	Exact identifier application number: M017
NATUHEAL JOINT BACK PAIN RELIEF	ARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4c923afa-4d1e-0776-e063-6294a90a2f54	2026-06-12	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	Aldermed Inc.	4a7b532e-b292-b595-e063-6394a90acc9c	2026-06-12	Warnings	Exact identifier application number: M017
MG PLUS MENTHOL	MENTHOL	RENU LABORATORIES, LLC	53737365-b985-3800-e063-6294a90a37f2	2026-06-11	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	7c78d980-fc94-498c-aec5-464c0c76c8f4	2026-06-11	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a47f1ed-d8cf-3b0b-e063-6394a90a932a	2026-06-11	Warnings	Exact identifier application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride	PRAMOXINE HYDROCHLORIDE	The Honey Pot Company LLC	81ab7fa7-d9b0-49dc-9782-02f37e588c5e	2026-06-10	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Cream with Lidocaine	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	ef176d33-10b9-ddb2-e053-2995a90a76e3	2026-06-10	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