Point Relief Cold Spot Pain Relieving

Product NDC: 51452-035
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 · 2 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		2026-10-15
excluded package	package	51452-035	51452-035-04	D	Discontinued by firm		2026-10-15

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	51452-035-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	51452-035-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	51452-035-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	51452-035-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	51452-035-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	51452-035-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	51452-035-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	51452-035-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	51452-035-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	51452-035-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	51452-035-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	51452-035-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	51452-035-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	51452-035-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	51452-035-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	51452-035-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	51452-035-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	51452-035-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	51452-035-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	51452-035-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	51452-035-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	51452-035-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	51452-035-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	51452-035-04	`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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunburn Relief Gel	LIDOCAINE HCL	Amazon.com Services LLC	adb638ec-4a7c-42f2-b249-0ac53a8dd4b2	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Amazon.com Services LLC	2acb1a6a-57e6-4915-b03a-89d1d2db3baf	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M017
Diphenhydramine Hydrochloride and Zinc Acetate	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	STRATEGIC SOURCING SERVICES LLC	ec0c9602-35cc-4bb6-b853-794a8b5bf42e	2026-03-03	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE 1%	PHARMACY CHOICE INC	4cdfe8b6-c332-7bf8-e063-6394a90abaec	2026-03-03	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	4c06c4a4-557b-8bb1-e063-6294a90a9125	2026-03-02	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Old East Main Co.	49173ec8-c94a-44c9-8a13-0f4b01b96cd6	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Old East Main Co.	6d87547f-bf4c-4dda-bd9d-32b576afd805	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M017
Still Standing	MENTHOL, UNSPECIFIED FORM	Natural Essentials Inc.	66974aaf-c82f-4fe9-bfb3-3430b80ac9f2	2026-03-02	Warnings	Exact identifier application number: M017
Lightning Pain Relief	MENTHOL	Clinical Resolution Laboratory, Inc.	80af21f5-dba8-42b0-8a65-ac5a94d83ca8	2026-03-02	Warnings	Exact identifier application number: M017
Icy Hot Lidocaine No-Mess	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	347f9a18-8ab6-47d3-9610-5b4e9ca5d53a	2026-03-02	Warnings	Exact identifier application number: M017
Gold Bond Maximum Strength Foot Pain Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	8e469076-2f5a-4de8-8d13-a38c072b9af8	2026-03-01	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	48ecbab9-13e0-d0fa-e063-6294a90a6ff2	2026-02-28	Warnings	Exact identifier application number: M017
NUMBING CREAMS	LIDOCAINE	Yongchun Lihui Trading Co., Ltd.	3b5e1a74-5946-4f1f-e063-6394a90a404b	2026-02-27	Warnings	Exact identifier application number: M017
Pain Relieving Gel	LIDOCAINE HYDROCHLORIDE	Chain Drug Marketing Association	b55b7253-2fd2-45cc-b94c-e92395ab0d2b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M017
MEDISTIK PROFESSIONAL DUAL ACTION	MENTHOL, METHYL SALICYLATE, EUCALUPTUS	Natureteq Inc.	99c7f08a-ab14-4371-9147-189f75cb6633	2026-02-27	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Walmart Inc.	309dcf5b-7166-976a-e063-6394a90af952	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M017
ASYSTEM Radical Relief Gel Roll-On	MENTHOL, METHYL SALICYLATE	Cosco International, Inc.	7239733e-5510-4a63-96c3-dd88b4a431a3	2026-02-27	Warnings	Exact identifier application number: M017
Icy Hot Pro Pain Massaging Balm	CAMPHOR AND MENTHOL	Chattem, Inc.	09e2b0cb-5186-4f9c-b256-edaced4ca014	2026-02-27	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE PAIN RELIEF	PAI Holdings, LLC dba PAI Pharma	963978de-8295-47ee-9b06-64c3521aa994	2026-02-26	Warnings	Exact identifier application number: M017
Tommie Copper Cooling Roller Lavender Scent	MENTHOL 4%	Tommie Copper, Inc.	4bbfd4d1-9036-bc20-e063-6394a90a3feb	2026-02-26	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
51452-035-02	51452003502	475 mL in 1 BOTTLE (51452-035-02)	475 ml	2019-04-01	0000-00-00	No	No	Current
51452-035-03	51452003503	3800 mL in 1 JUG (51452-035-03)	3800 ml	2019-04-01	0000-00-00	No	No	Current
51452-035-04	51452003504	420 mL in 1 TUBE (51452-035-04)	420 ml	2019-04-01	0000-00-00	No	No	Current
51452-035-05	51452003505	950 mL in 1 BOTTLE (51452-035-05)	950 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