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 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Menper Distributors Inc.	ad940dc8-9403-44cf-aed3-6e538cbe488b	2025-07-22	Warnings	Exact identifier application number: M017
Balsamo de Vaca Mascura	METHYL SALICYLATE	Menper Distributors Inc.	321b6f1f-c802-4b96-99d3-e77217da11a3	2025-07-22	Warnings	Exact identifier application number: M017
Abejas y Viboras Roll On	METHYL SALICYLATE	Menper Distributors Inc.	bedf3b36-7def-099f-e053-2a95a90ac15b	2025-07-22	Warnings	Exact identifier application number: M017
HealthWise Flexible 4% Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3869cc18-5494-6142-e063-6394a90a75e5	2025-07-22	Warnings	Exact identifier application number: M017
Arthcal 4% Lidocaine Patches	LIDOCAINE	Beijing JUNGE Technology Co., Ltd.	2e531194-67ad-c645-e063-6394a90a916c	2025-07-22	Warnings	Exact identifier application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALM	MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	2025-07-22	Warnings	Exact identifier application number: M017
Cold Sore Fast-Acting Pain Relief	GLYCERIN AND LIDOCAINE	Blistex Inc.	c7511322-dd6c-441c-bf7d-ad4f0c14956a	2025-07-22	Warnings	Exact identifier application number: M017
Mountain Ice Sports Pain Relief	MENTHOL, CAMPHOR	Mountainside Medical Equipment, Inc.	c1f5512c-67b1-4ff0-b1a5-616e883d436f	2025-07-21	Warnings	Exact identifier application number: M017
Stopain Clinical Roll-On	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	27703209-fdac-4620-a445-d89a84bc853d	2025-07-21	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Exact identifier application number: M017
Dr Kevin Khalili Pain Relief Cream	MENTHOL	DR. KHALILI LLC	3a79b38c-9adc-60dd-e063-6394a90a5b30	2025-07-21	Warnings	Exact identifier application number: M017
ARTHRITIS PAIN RELIEF	CAMPHOR, CAPSAICIN, METHYL SALICYLATE	YUNNAN BAIYAO GROUP CO., LTD.	671c57f0-3c6f-4416-bc81-f6930fef327b	2025-07-21	Warnings	Exact identifier application number: M017
GoodSense Cooling Pain Relief	MENTHOL	Geiss, Destin & Dunn, Inc	2e5e1375-df07-9a43-e063-6394a90a9938	2025-07-20	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Cooling	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a7eae5dc-9db6-4bdf-9179-76060e75e044	2025-07-18	Warnings	Exact identifier application number: M017
Nicotine Patches	NICOTINE PATCHES	Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.	3a1abd26-c0aa-8a65-e063-6294a90ab66e	2025-07-17	Warnings	Exact identifier application number: M017
Aouiv 4% Lidocaine Numbing Cream	4% LIDOCAINE NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	3a221dd2-e945-bd0e-e063-6294a90a8fb9	2025-07-17	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	24538037-1d74-48a0-b909-98ecc57651fe	2025-07-17	Warnings	Exact identifier application number: M017
Hydrocortisone anti-itch plus	HYDROCORTISONE	Wal-Mart Stores, Inc.	a0c6e180-b385-4a9b-a9cf-84a551f533d0	2025-07-16	Warnings	Exact identifier application number: M017
OTC Rescue Lidocaine Pain Relief Patch	LIDOCAINE	Veridian Healthcare	0e742fc6-5f76-d202-e063-6394a90acf31	2025-07-16	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	ae4b7cd6-8b5d-4d25-86f9-72260638bb94	2025-07-16	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