SUGARLOAF ORGANICS MENTHOL REVIVE

Product NDC: 76348-996
11-digit product format: 763480996
Labeler code: 76348
Product ID: 76348-996_3ce4cb1d-6369-4b5b-e063-6294a90a9e81
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: 2023-04-25
Substance: MENTHOL
Active strength: 5.9 g/118mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 16 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
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76348-996-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	76348-996-01	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	76348-996-01	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	76348-996-01	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	76348-996-01	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	76348-996-01	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	76348-996-01	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	76348-996-01	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: SUGARLOAF ORGANICS MENTHOL REVIVE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.9 g/118mL

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
fa2f9539-b703-a00b-e053-6394a90ae309	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4d7a96d5-8256-4268-9a6c-25ea66d321fe	Product name	1	20180814
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-996-01	2025-08-27	C162847	48780-1	2cef2736-6068-d83d-e063-dadaa90ab31f	SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM
76348-996-01	2025-01-30	C162847	48780-1	2cef2736-6068-d83d-e063-dadaa90ab31f	SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-996-01	SUGARLOAF ORGANICS MENTHOL REVIVE	1 in 1 BOX	CREAM	1		2
76348-996-04	SUGARLOAF ORGANICS MENTHOL REVIVE	118 mL in 1 JAR	CREAM	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-996	SUGARLOAF ORGANICS MENTHOL REVIVE (MENTHOL) CREAM [RENU LABORATORIES, INC.]	1	Current NDC, 2 package rows	20230428_fa2f9539-b703-a00b-e053-6394a90ae309.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 3 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Pain Relief Lidocaine XL	LIDOCAINE	CVS Pharmacy	4aa286e3-e274-8095-e063-6394a90ae871	2026-08-26	Warnings	Exact identifier application number: M017
TERAPIA DE DIA Y NOCHE	PAIN RELIEVING PATCH	DW SUPPORT LLC	59f44135-865b-9d7d-e063-6294a90a9dd9	2026-08-26	Warnings	Exact identifier application number: M017
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE	Cardinal Health, 110 dba LEADER	025d508b-ec4f-466c-b3e8-ba9b18d07b46	2026-08-26	Warnings	Exact identifier application number: M017
Inknows Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	59eb9c12-9e00-0171-e063-6394a90a8342	2026-08-25	Warnings	Exact identifier application number: M017
Lidomar	LIDOMAR	Oncora Pharma, LLC	215bfdca-60bf-480b-b02e-902de52fe5e8	2026-08-25	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	5f87d7fb-f258-48b0-8b60-1055e22ebd71	2026-08-25	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c7e13f-b9ea-023a-e063-6294a90a79e0	2026-08-24	Warnings	Exact identifier application number: M017
KNEE PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c8b33a-7d4f-2c6e-e063-6394a90a7929	2026-08-24	Warnings	Exact identifier application number: M017
Bovonte Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5958cc29-c449-56a7-e063-6394a90a960b	2026-08-24	Warnings	Exact identifier application number: M017
HUSTLE BUTTER NUMBING	LIDOCAINE HYDROCHLORIDE	H.B.D. D.I.S.T. INC.	d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e	2026-08-24	Warnings	Exact identifier application number: M017
JELVOXA NECK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a3d60a-26b5-e6a6-e063-6294a90a42bd	2026-08-22	Warnings	Exact identifier application number: M017
JELVOXA DMSO	CAMPHOR CAPSAICIN MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a43e2c-d258-34b5-e063-6394a90a09bf	2026-08-22	Warnings	Exact identifier application number: M017
Capsaicin 0.035 Percent	CAPSAICIN	Preferred Pharmaceuticals Inc.	0fabc025-4208-45f5-b3c2-543ae3a2df41	2026-08-21	Warnings	Exact identifier application number: M017
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	3b8c2419-7a78-2731-e054-00144ff8d46c	2026-08-21	Warnings	Exact identifier application number: M017
PARCHE FRIO	METHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCH	DW SUPPORT LLC	5970a6f7-b273-9bb1-e063-6394a90afc79	2026-08-21	Warnings	Exact identifier application number: M017
Enokon Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	5976e667-e506-1d11-e063-6394a90a6809	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN TIGER Patch	TIGER PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5977cbb5-94c7-cb24-e063-6294a90a2e07	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN Nicotine Patches	NICOTINE PATCHES	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5978258a-549e-50e6-e063-6394a90a3d86	2026-08-20	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
76348-996-01	76348099601	1 JAR in 1 BOX (76348-996-01) / 118 mL in 1 JAR (76348-996-04)	1 jar	2023-04-25	No	No	Current
76348-996-04	76348099604	118 mL in 1 JAR	118 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM	RENU LABORATORIES, LLC \| RENU LABORATORIES LLC	2025-08-21	HUMAN OTC DRUG LABEL	2