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 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35ac19-6883-a733-e063-6294a90ad22d	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	cfe8114b-df65-064b-e053-2a95a90a33f6	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Exact identifier application number: M017
Licefreee AfterLice	PRAMOXINE HCI	Tec Laboratories Inc.	06c4cc42-a215-3949-e063-6394a90a665e	2024-11-05	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	ASO LLC	cb9505b7-222d-3a24-e053-2a95a90a0b64	2024-11-05	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Exact identifier application number: M017
Eagle Green Balm	CAMPHOR MENTHOL	Borden Company (Private) Limited	6f7a796b-a31c-0e60-e053-2a91aa0a022b	2024-11-04	Warnings	Exact identifier application number: M017
Muscular Balm	CAPSAICIN MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	ed79f14e-6b3d-4bf2-9c34-d019c1ba2582	2024-11-04	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Exact identifier application number: M017
Walgreens Ice Blue Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Walgreen Company	1c0ee442-ffd2-4f6c-aab2-f70e295378ad	2024-11-04	Warnings	Exact identifier application number: M017
Walgreen Cool n Heat Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM	Walgreen Company	d5c79476-dde8-4a85-8878-bc2ac3a3d70b	2024-11-04	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE	STRATUS PHARMACEUTICALS INC	87a4f559-a4f6-4b9f-98de-b55b073a11c6	2024-11-01	Warnings	Exact identifier application number: M017
Walgreens Nerve Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Walgreen Company	83849eca-e02f-4b43-b3a7-b25e987e08a8	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Arnica White	CAMPHOR	Sanvall Enterprises, Inc	192039a2-aed6-821b-e063-6394a90a7f29	2024-10-31	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