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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Exact identifier application number: M017
Jelcaine Sterile	LIDOCAINE HCL JELLY USP, 2%	Brookfield Pharmaceuticals, LLC	1a39d1de-7aa2-3068-e063-6394a90aed85	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	c6e86a0f-6f9b-45b7-86ce-0bb1c198061a	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	97ae1993-7268-4b7f-92e2-6004337d5650	2025-11-10	Warnings	Exact identifier application number: M017
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	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