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 97 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Muscle Recovery Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	1c347267-b653-41bf-9967-7feff17c38af	2025-03-27	Warnings	Exact identifier application number: M017
Soothing Lavender Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	ef26523a-b2f2-466e-89ad-f293cd64decb	2025-03-27	Warnings	Exact identifier application number: M017
Achelon Lidocaine Patch	LIDOCAINE PATCH 4%	Achelon, Inc	31408e21-e58d-6db5-e063-6294a90aa4bc	2025-03-26	Warnings	Exact identifier application number: M017
Achelon Lidocaine Patch	LIDOCAINE PATCH 4%	Achelon, Inc	3143bb72-2969-d66e-e063-6294a90a4604	2025-03-26	Warnings	Exact identifier application number: M017
Parche Leon	CAPSAICIN, CAMPHOR, MENTHOL	Pharmadel LLC	a8f266fa-6e43-559e-e053-2995a90a2c75	2025-03-26	Warnings	Exact identifier application number: M017
Adellina Numbing Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	314a83fe-8bdb-766f-e063-6294a90a61c6	2025-03-26	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Menthol Patch	LIDOCAINE AND MENTHOL	Veridian Healthcare	312f15fe-9297-2dc2-e063-6294a90a6f4d	2025-03-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3130729d-1679-90cd-e063-6294a90a21e6	2025-03-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	31314dda-6199-574d-e063-6394a90aae7a	2025-03-25	Warnings	Exact identifier application number: M017
RWSEFK Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	31366793-f8a6-a2c4-e063-6294a90acbfc	2025-03-25	Warnings	Exact identifier application number: M017
Forticept Wounds and Burns Hydrogel	BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Lidan, inc.	c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f	2025-03-25	Warnings	Exact identifier application number: M017
MQ Pain Relieving Patch	PAIN RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0978ff22-c357-e266-e063-6394a90a98a4	2025-03-24	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Advanced Rx of Tennessee, LLC	30c97646-db06-df84-e063-6394a90a7743	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF	CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	5f904369-5f21-4907-98de-df23bce30823	2025-03-20	Warnings	Exact identifier application number: M017
DermaCort Anti-itch	HYDROCORTISONE	Melaleuca, Inc.	24044b0f-dd1e-4762-82b8-7a28b08c2f77	2025-03-20	Warnings	Exact identifier application number: M017
AUVON Lidocaine Menthol Pain Relief Patch	LIDOCAINE AND MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	300cf469-5ca2-a40d-e063-6294a90a6801	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a3af6e1-0281-462e-85e7-144cc5d46f32	2025-03-19	Warnings	Exact identifier application number: M017
Lidocaine 4%	LIDOCAINE	Innovida Pharmaeutique Corporation	eb83a3dd-557e-4334-b806-5fc05e9175a3	2025-03-19	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	c04059e9-8175-46c2-8582-f84ef193abd3	2025-03-19	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