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 14 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roll Pain Away	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547e647b-0205-221c-e063-6294a90a757c	2026-06-17	Warnings	Exact identifier application number: M017
Roll Pain Away Lemongrass	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547ef5c0-bc31-d83e-e063-6394a90abfa6	2026-06-17	Warnings	Exact identifier application number: M017
Roll Pain Away Lavender	CAPSAICIN	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	547ef2d9-f5c7-9de1-e063-6394a90a218b	2026-06-17	Warnings	Exact identifier application number: M017
Velloryn EXTRA STRENGTH NEUROPATHY	VELLORYN EXTRA STRENGTH NEUROPATHY	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	547f755f-c65c-37ef-e063-6394a90aa220	2026-06-17	Warnings	Exact identifier application number: M017
Neoteric Diabetic Skin Care 4 oz.	DIMETHICONE	RNA PHARMA LLC	536f4e79-201b-7100-e063-6394a90a4f82	2026-06-16	Warnings	Exact identifier application number: M017
Medi First Extra Strength Itch Relief	DIPHENHYDRAMINE, ZINC ACETATE	Unifirst First Aid Corporation	54614e5b-8c72-d308-e063-6294a90a405d	2026-06-16	Warnings	Exact identifier application number: M017
Blue Ice Analgesic	MENTHOL	Delon Laboratories (1990) Ltd	184ed488-6e62-40c6-bb71-1d523280fd6b	2026-06-16	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch Cream	HYDROCORTISONE	Unifirst First Aid Corporation	49f04e5d-746d-cbe9-e063-6294a90a7e88	2026-06-16	Warnings	Exact identifier application number: M017
Lidozall Pro	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff	2026-06-16	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Cool	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	41590ba1-32bb-4352-97ba-d6a3cc9d0546	2026-06-15	Warnings	Exact identifier application number: M017
HIGH POTENCY PAIN RELIEF	CAPSAICIN	Xiamen Weisiqi Technology Co., Ltd.	543949a4-86ed-3734-e063-6394a90a24f2	2026-06-14	Warnings	Exact identifier application number: M017
Natucure HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	49e402ed-d314-e896-e063-6294a90a826b	2026-06-14	Warnings	Exact identifier application number: M017
Nieapf NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e7534f-bccf-4ef4-e063-6294a90aeb7f	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	HEALMUSZ NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49976ff7-49a4-e4ed-e063-6294a90a3f78	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ HEMORRHOID FISSURE	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSURE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a342ac0-6a8d-3408-e063-6394a90a9a10	2026-06-14	Warnings	Exact identifier application number: M017
BOTASUN QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	4fa00db9-def5-dcfa-e063-6394a90ac8c2	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4cbb7df5-5771-ce4b-e063-6294a90aab80	2026-06-14	Warnings	Exact identifier application number: M017
HEALMUSZ ECZEMA	HYDROCORTISONE 1% ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	511e54e0-2abe-fb76-e063-6294a90ada68	2026-06-14	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-ItchCream	HYDROCORTISONE	Acme United Corporation	5425fc2b-4f25-3e64-e063-6394a90aff49	2026-06-13	Warnings	Exact identifier application number: M017
Icy Hot Pain Relieving Balm	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	40c8c02f-fa5f-4e80-81a0-48271fa6f94b	2026-06-12	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