Point Relief Cold Spot Pain Relieving

Product NDC: 51452-035
Requested package NDC: 51452-035-01
11-digit product format: 514520035
Labeler code: 51452
Product ID: 51452-035_0fc4ec9e-6c21-5a8c-e063-6394a90a11ef
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Fabrication Enterprises
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-01
Substance: MENTHOL
Active strength: 120 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51452-035	51452-035-01	D	Discontinued by firm		2026-10-27

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Point Relief Cold Spot Pain Relieving
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	120 mg/mL

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2121666	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ad5d6f04-15e6-4548-95c2-32271c186bc1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51452-035-01	Point Relief Cold Spot Pain Relieving	120 mL in 1 BOTTLE	GEL	120	4
51452-035-02	Point Relief Cold Spot Pain Relieving	475 mL in 1 BOTTLE	GEL	475	4
51452-035-03	Point Relief Cold Spot Pain Relieving	3800 mL in 1 JUG	GEL	3800	4
51452-035-04	Point Relief Cold Spot Pain Relieving	420 mL in 1 TUBE	GEL	420	4
51452-035-05	Point Relief Cold Spot Pain Relieving	950 mL in 1 BOTTLE	GEL	950	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51452-035	POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES]	4	Current NDC, Legacy NDC, 5 package rows	20240126_ad5d6f04-15e6-4548-95c2-32271c186bc1.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 96 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a36a241-37a9-445a-a6e0-97709a7457a8	2025-03-19	Warnings	Exact identifier application number: M017
Herb Analgesic	HERB ANALGESIC PASTE	Changsha Maocheng Trading Co., Ltd	29373587-9eff-6ea0-e063-6394a90a23b2	2025-03-18	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	f469b446-58a0-4be3-884f-d622b9d074f8	2025-03-17	Warnings	Exact identifier application number: M017
Auvon 4% Menthol Pain Relief Gel	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	2dacd6fe-7d69-bcf0-e063-6294a90a0351	2025-03-14	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	2025-03-14	Warnings	Exact identifier application number: M017
AY BENDITO THERMOACTIVE	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	304d71b6-91c8-b2b6-e063-6394a90ab669	2025-03-14	Warnings	Exact identifier application number: M017
Hot/Cold Medicated Patch	HOT COLD PATCH	Dynarex	999881b3-287e-d975-e053-2995a90a87e3	2025-03-14	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2121666	menthol 0.12 MG/MG Topical Gel	PSN	ad5d6f04-15e6-4548-95c2-32271c186bc1	4
2121666	menthol 0.12 MG/MG Topical Gel	SCD	ad5d6f04-15e6-4548-95c2-32271c186bc1	4
2121666	menthol 12 % Topical Gel	SY	ad5d6f04-15e6-4548-95c2-32271c186bc1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51452-035-01	51452003501	120 mL in 1 BOTTLE (51452-035-01)	120 ml	2019-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Point Relief Cold Spot Pain Relieving Gel	Fabrication Enterprises	2024-01-25	HUMAN OTC DRUG LABEL	4