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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLT 2	LIDOCAINE HCL	CENTURA PHARMACEUTICALS INC	41dc85ec-d79b-0a32-e054-00144ff8d46c	2026-01-12	Warnings	Exact identifier application number: M017
Mineral Ice Pain Relieving	MENTHOL	Crown Laboratories	7b30076a-0af6-2f74-e053-2a91aa0ae08d	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE	Crown Laboratories	19b0ce1b-e147-01a1-e063-6394a90af808	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	HY-VEE, INC	48350b54-8d9a-48c4-e063-6394a90ac040	2026-01-12	Warnings	Exact identifier application number: M017
LidoPlus Pain Relief	LIDOCAINE HYDROCHLORIDE	Centura Pharmaceuticals, Inc	07bacc6c-60a6-4297-8663-904a22bdc040	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f2277e27-868b-57ef-e053-2a95a90abf28	2026-01-12	Warnings	Exact identifier application number: M017
BLT 3	TETRACAINE	CENTURA PHARMACEUTICALS INC	401a0d22-1181-02ac-e054-00144ff88e88	2026-01-12	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	0c901f64-6890-45c0-9ca7-ee9de87903c4	2026-01-12	Warnings	Exact identifier application number: M017
Goodsense Oral Pain Relief	BENZOCAINE	Geiss, Destin and Dunn, Inc.	eb461b70-d10f-4e11-8374-e43713f3504d	2026-01-12	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier application number: M017
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier application number: M017
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier application number: M017
DG Health Pain Relieving	LIDOCAINE HCL	DOLGENCORP, LLC	923aeb4c-049f-4ecc-a77e-9ffa0e236d4e	2026-01-11	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare	46b84e0b-78a9-4cde-9f90-e165b5419162	2026-01-09	Warnings	Exact identifier application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On	MENTHOL	Inspec Solutions	12ff9b9a-73e5-ce31-e063-6294a90aeaf8	2026-01-09	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bb0278c9-eaff-d435-e053-2995a90a202a	2026-01-09	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