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 139 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Exact identifier application number: M017
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier application number: M017
FIRST SHIELD	LIDOCAINE HCI	Ever Ready First Aid	e022bf8f-3dd8-de22-e053-2995a90a219b	2024-01-15	Warnings	Exact identifier application number: M017
Flexigen	MENTHOL 1.25%	Derma Care Research Labs, LLC	e9ae2682-59b4-e796-e053-2995a90af921	2024-01-15	Warnings	Exact identifier application number: M017
Vita-P Oral and Nasal	MENTHOL 1%	Beijing HKKY Medical Tech. Co., Ltd.	537c3843-1c92-41c6-b724-52701bbddeab	2024-01-13	Warnings	Exact identifier application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Exact identifier application number: M017
Cool n Heat	COOL N HEAT	NeilMed Pharmaceuticals, Inc.	a24cde17-280b-8358-e053-2a95a90af67d	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Anti-Itch	ANTI-ITCH SPRAY	NeilMed Pharmaceuticals Inc.	b3d34d9e-85d9-df4e-e053-2a95a90ac8d9	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Hot and Cold Pain Relief	PAIN RELIEF SPRAY	NeilMed Pharmaceuticals Inc.	b3d02111-7499-c2d4-e053-2a95a90ae1de	2024-01-11	Warnings	Exact identifier application number: M017
Cooling Itch Relief	COOLING ITCH RELIEF	NeilMed Pharmaceuticals, Inc	a24bdea0-18e8-8a5e-e053-2995a90acea2	2024-01-11	Warnings	Exact identifier application number: M017
Lightning X Burn	LIDOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0e69a971-0c6e-6ebe-e063-6394a90a0b33	2024-01-08	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Exact identifier application number: M017
2nd CHANCE MOBILITY Pain Relief	HISTAMINE DIHYDROCHLORIDE	ALPHA NUTRITION, LLC	575097ac-9fc9-4391-99d1-dff9b34817e3	2024-01-08	Warnings	Exact identifier application number: M017
Tiger Balm Arthritis Rub	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	80932288-4797-40d3-aa8a-6af686fb67ad	2024-01-08	Warnings	Exact identifier application number: M017
OPRAVA	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	05552560-e283-5eba-e063-6294a90a65f7	2024-01-06	Warnings	Exact identifier application number: M017
MED O-3 BIO-	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	02707552-03d9-3ad2-e063-6294a90a3472	2024-01-06	Warnings	Exact identifier application number: M017
Sumifun Knee Relieving Patch	KNEE RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e7e73ec-ab33-9235-e063-6394a90ad950	2024-01-06	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE	YYBA Corp	de6dc194-c6ef-4cb5-be3f-e772ace9abaf	2024-01-03	Warnings	Exact identifier application number: M017
Equate Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Walmart Inc.	0cdc9323-f5c3-468c-a7ae-83dfd2d76626	2024-01-03	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