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 27 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPARTAN	LIDOCAINE	TIV PRIME SRL	4e04146a-ed19-2271-e063-6394a90a50f0	2026-03-27	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Lidocaine	LIDOCAINE	Walgreen Co.	41d5bdc4-66c8-31ab-e063-6394a90a1195	2026-03-27	Warnings	Exact identifier application number: M017
Walgreens Cool N Heat Patch	LIDOCAINE, MENTHOL	Walgreen Co.	41d64a88-90fc-27ca-e063-6294a90a602b	2026-03-27	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated	CAMPHOR, MENTHOL	The Mentholatum Company	4e05d134-6c7f-1501-e063-6294a90ad27d	2026-03-27	Warnings	Exact identifier application number: M017
Walgreens Cool N Heat Patch XL	MENTHOL	Walgreen Co.	41e92435-7f77-a593-e063-6394a90a4b38	2026-03-27	Warnings	Exact identifier application number: M017
Walgreens Cool N Heat Back Patch	MENTHOL	Walgreen Co.	41e81110-4b79-1fa6-e063-6394a90ae90c	2026-03-27	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated Elderberry Acai	CAMPHOR, MENTHOL	The Mentholatum Company	4e0743a6-d450-043b-e063-6394a90ad1c2	2026-03-27	Warnings	Exact identifier application number: M017
QFSN Pain Relief Cream	PAIN RELIEF CREAM	Qiaofusheng Pharmaceuticals Co., Ltd.	4d215da1-87f5-d35d-e063-6394a90ac348	2026-03-27	Warnings	Exact identifier application number: M017
FlexSport Roll On	METHYL SALICYLATE	Pharmadel LLC	bf8de3da-7628-6112-e053-2995a90a8e16	2026-03-26	Warnings	Exact identifier application number: M017
Kofal Original	METHYL SALICYLATE	Pharmadel LLC	984780fd-496b-150b-e053-2995a90aed77	2026-03-26	Warnings	Exact identifier application number: M017
Kofal Fuerte	METHYL SALICYLATE	Pharmadel LLC	98488a07-eba0-2b4e-e053-2995a90ad6ab	2026-03-26	Warnings	Exact identifier application number: M017
Kofal Max Power	MENTHOL	Pharmadel LLC	fe1f1408-b0cb-67a4-e053-6394a90ad609	2026-03-26	Warnings	Exact identifier application number: M017
Kofal	METHYL SALICYLATE	Pharmadel LLC	9cac377d-97bc-f0b7-e053-2a95a90a2e12	2026-03-26	Warnings	Exact identifier application number: M017
Milagroso	CAMPHOR	Pharmadel LLC	12b0401c-84d5-07cd-e063-6394a90a052c	2026-03-26	Warnings	Exact identifier application number: M017
Ubredol	METHYL SALICYLATE	Pharmadel LLC	fe96eead-1722-c05d-e053-6394a90a850f	2026-03-26	Warnings	Exact identifier application number: M017
DZUL PAIN FREEZE INSTANT PAIN RELIEF	MENTHOL	Caball Sales, Inc.	4df3abcc-17f3-17f2-e063-6294a90afcca	2026-03-26	Warnings	Exact identifier application number: M017
Equate Cool and Heat Extra Strength	MENTHOL	Wal-Mart Stores Inc	ca3088a7-e1ec-4e69-80d9-fd0051bde938	2026-03-25	Warnings	Exact identifier application number: M017
Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	2ea95529-ec4b-c2ce-e063-6394a90a0739	2026-03-25	Warnings	Exact identifier application number: M017
NUMBING CREAMS	MENTHOL LIDOCAINE	Yongchun Lihui Trading Co., Ltd.	4dd38cdf-d644-6da0-e063-6294a90afb3d	2026-03-25	Warnings	Exact identifier application number: M017
ANTIPHLAMINE	L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE	Masaem Company	4dd3ab12-6cd3-1060-e063-6394a90a2dec	2026-03-25	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