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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eagle Brand Muscle Rub	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	06cb845c-cc53-1f1d-e063-6394a90a8c01	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0ef7c3aa-94a3-9fe9-e063-6394a90ab13d	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	5071f145-49f7-0855-e063-6394a90a8f26	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Refresh	CAMPHOR, MENTHOL	PT. EAGLE INDO PHARMA	09260c31-56a3-07aa-e063-6394a90a95fd	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Muscle Rub	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	5072ad57-9fa7-ddba-e063-6394a90a319b	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	PT. EAGLE INDO PHARMA	09235f26-2262-6ca2-e063-6394a90ad8f1	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0f333f93-bec6-72d5-e063-6394a90a4e3f	2026-04-27	Warnings	Exact identifier application number: M017
HIP PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	502f1f9e-8552-ca7b-e063-6394a90a7c53	2026-04-24	Warnings	Exact identifier application number: M017
SOMBRA WARM THERAPY	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	de78dba9-53b3-4dbd-9dd2-6a692378da34	2026-04-24	Warnings	Exact identifier application number: M017
Rite Aid Itch Relief	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Rite Aid	e285df43-317c-d862-e053-2a95a90acdce	2026-04-23	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Unflavored	HYDROCORTISONE	Lovely Skin, Inc.	9ff8db07-ad6d-4865-a534-94bd8312957e	2026-04-23	Warnings	Exact identifier application number: M017
DCH Labs Cortisone	HYDROCORTISONE 1%	Derma Care Research Labs	5025f53a-02e0-0f6a-e063-6394a90adbbf	2026-04-23	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	2026-04-22	Warnings	Exact identifier application number: M017
Dr. Carrasco Pain Relief	MENTHOL	Carrasco Enterprises, Inc.	befa8526-f468-428e-a829-422c2ea48612	2026-04-21	Warnings	Exact identifier application number: M017
HealthWise Feminine Anti-itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	4ff88b9e-5869-a1cb-e063-6294a90a87b7	2026-04-21	Warnings	Exact identifier application number: M017
SOMBRA COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	2026-04-21	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	c4c86a8f-1d57-49d2-a65f-acb0dccf2f87	2026-04-21	Warnings	Exact identifier application number: M017
KOXUO Arnica Bruise Cream	ARNICA BRUISE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5003bf83-fa01-b01a-e063-6294a90ad37f	2026-04-21	Warnings	Exact identifier application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% Lidocaine	KT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLON	Clarion Brands LLC	4f82993c-ebc4-5787-e063-6294a90a12d6	2026-04-20	Warnings	Exact identifier application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% Menthol	KT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOL	Clarion Brands LLC	4fe64056-f3c6-bc76-e063-6294a90a7e62	2026-04-20	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