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		2026-10-21
excluded package	package	51452-035	51452-035-04	D	Discontinued by firm		2026-10-21

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 128 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Real Time Pain Relief Maxx Topical Analgesic	MENTHOL	REAL TIME PRODUCTS, INC	f45eb95a-2813-4124-bdb0-54e078a8237d	2024-08-20	Warnings	Exact identifier application number: M017
Theracare Lidocaine Pain relief	LIDOCAINE	Veridian Healthcare	1d8a3679-637d-94c0-e063-6294a90a9ecf	2024-08-19	Warnings	Exact identifier application number: M017
LidoSync	LIDOCAINE, MENTHOL	iON Pharma, LLC	200f883c-439a-3b99-e063-6394a90aed10	2024-08-19	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	09243a23-1f17-f77b-e063-6394a90a0b22	2024-08-19	Warnings	Exact identifier application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Exact identifier application number: M017
Rite Aid Pain Relieving Roll-On	LIDOCAINE HCL	Rite Aid Corporation	1406590c-667c-84eb-e063-6294a90a5052	2024-08-16	Warnings	Exact identifier application number: M017
Nuvira	CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%	Strand Health Group	ff448183-03cf-df2d-e053-6394a90a77f0	2024-08-16	Warnings	Exact identifier application number: M017
FLANAX	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Belmora LLC	5e06c688-a086-4c1c-8dab-fcead61fef40	2024-08-13	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL	Pain Relieving Spray Inc.	1f44466f-044f-70fe-e063-6294a90ad575	2024-08-09	Warnings	Exact identifier application number: M017
Meijer Cold Therapy Pain Relieving	MENTHOL	Meijer Inc	1c5b55e3-f859-71b6-e063-6294a90a633b	2024-08-08	Warnings	Exact identifier application number: M017
HealthWise Soothing Cold Therapy Gel	MENTHOL 4%	Veridian Healthcare	1f09ccdd-09d8-6a8d-e063-6394a90a184f	2024-08-08	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	fbbbcc67-b46d-d41a-e053-6294a90aa55d	2024-08-08	Warnings	Exact identifier application number: M017
Cheezheng Pain Relief Cream	MENTHOL	Tibet Cheezheng Tibetan Medicine Co. Ltd	37279a3f-9207-4e4c-90d6-52735044f104	2024-08-07	Warnings	Exact identifier application number: M017
CVS Health Hydrocortisone Anti Itch	HYDROCORTISONE	CVS Health	546a1b8a-8254-432a-85c4-38ebee5ad568	2024-08-07	Warnings	Exact identifier application number: M017
SANTO REMEDIO Alivio Pain Relieving Lavender Scent	LIDOCAINE HYDROCHLORIDE, MENTHOL	SANTO REMEDIO LLC	ab53c7f2-a768-4f36-89d6-e128a1a940c2	2024-08-05	Warnings	Exact identifier application number: M017
CVS Health Maximum Strength Hydrocortisone	HYDROCORTISONE OINTMENT	CVS Health	ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3	2024-08-02	Warnings	Exact identifier application number: M017
Anti-Itch Vulva Cream 1 Hydrocortisone Acetate	HYDROCORTISONE ACETATE	The Honey Pot Company LLC	6f32b536-6ebf-49a8-abb6-2a1daae2f6d7	2024-08-01	Warnings	Exact identifier application number: M017
Anti Itch Soothing 1 Pramoxine Hydrochloride	PRAMOXINE HYDROCHLORIDE	The Honey Pot Company LLC	8bfeea34-25d5-4721-a17f-d9f1d0084cc3	2024-08-01	Warnings	Exact identifier application number: M017
AVON footworks Arthritis Achy Foot and Muscle	METHYL SALICYLATE	The Avon Company	1f440f60-cfc4-511e-e063-6294a90a87db	2024-08-01	Warnings	Exact identifier application number: M017
AVON footworks Maximum Strength Cracked Heel	BENZALKONIUM CHLORIDE, LIDOCAINE	The Avon Company	1f45752e-4a55-431e-e063-6294a90aa57a	2024-08-01	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