Cold Spot

Product NDC: 51452-001
11-digit product format: 514520001
Labeler code: 51452
Product ID: 51452-001_8bdc5379-f2d4-4c2b-affa-8fdd375c7713
Type: HUMAN OTC DRUG
Nonproprietary name: menthol, methyl salicylate
Dosage form: GEL
Route: TOPICAL
Labeler: Fabrication Enterprises
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-08-24
Marketing end: 0000-00-00
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 58 mL/480mL; mL/480mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51452-001		I	Inactivated by FDA	2026-10-05
excluded product	product	51452-001		I	Inactivated by FDA	2026-10-05
excluded product	product	51452-001		D	Discontinued by firm	2026-10-05
excluded product	product	51452-001		D	Discontinued by firm	2026-10-05
excluded product	product	51452-001		I	Inactivated by FDA	2026-10-05
excluded package	package	51452-001	51452-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	51452-001	51452-001-00	I	Inactivated by FDA	2026-10-05
excluded package	package	51452-001	51452-001-28	D	Discontinued by firm	2026-10-05
excluded package	package	51452-001	51452-001-32	D	Discontinued by firm	2026-10-05
excluded package	package	51452-001	51452-001-16	I	Inactivated by FDA	2026-10-05

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 3 · 180 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51452-001-28	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51452-001-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51452-001-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51452-001-32	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51452-001-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51452-001-28	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51452-001-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51452-001-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51452-001-32	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51452-001-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51452-001-28	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51452-001-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51452-001-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51452-001-32	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51452-001-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51452-001-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51452-001-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51452-001-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51452-001-32	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51452-001-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51452-001-28	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51452-001-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51452-001-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51452-001-32	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51452-001-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51452-001-28	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51452-001-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51452-001-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51452-001-32	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51452-001-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51452-001-00	2019-10-29	C162847	48780-1	960f7f55-cdd9-8e05-e053-dbdaa90a074a	Cold Spot Point Relief Pain relieving Gel - 5 G
51452-001-04	2019-10-29	C162847	48780-1	960f7f55-cd55-8e05-e053-dbdaa90a074a	Cold Spot Point Relief Pain relieving Gel - 4 oz.
51452-001-16	2019-10-29	C162847	48780-1	960f7f55-c87b-8e05-e053-dbdaa90a074a	Cold Spot Point Relief Pain relieving Gel - 16 oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51452-001-00	Cold SpotPoint Relief	5 g in 1 BOTTLE, DISPENSING	GEL	5		4
51452-001-04	Cold SpotPoint Relief	120 mL in 1 TUBE	GEL	120		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
menthol	ACTIVE INGREDIENT	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
menthol	ACTIVE MOIETY	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
alcohol	INACTIVE INGREDIENT	3K9958V90M	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Eucalyptus Globulus Leaf	INACTIVE INGREDIENT	S546YLW6E6	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Ilex Paraguariensis Leaf	INACTIVE INGREDIENT	1Q953B4O4F	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
water	INACTIVE INGREDIENT	059QF0KO0R	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	7
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Menthol	ACTIVE MOIETY	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
alcohol	INACTIVE INGREDIENT	3K9958V90M	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Eucalyptus Globulus LEAF	INACTIVE INGREDIENT	S546YLW6E6	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Ilex Paraguariensis LeaF	INACTIVE INGREDIENT	1Q953B4O4F	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Ilex Paraguariensis Leaf	INACTIVE INGREDIENT	1Q953B4O4F	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
water	INACTIVE INGREDIENT	059QF0KO0R	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
Menthol	ACTIVE MOIETY	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
Eucalyptus Globulus LEAF	INACTIVE INGREDIENT	S546YLW6E6	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
Ilex Paraguariensis LeaF	INACTIVE INGREDIENT	1Q953B4O4F	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
water	INACTIVE INGREDIENT	059QF0KO0R	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51452-001	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	4	Legacy NDC, 1 package rows	20101130_823ccf6b-f494-4ddb-9547-431c2367d65f.zip
51452-001	COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]	3	Legacy NDC, 1 package rows	20101130_7013706a-3afe-430f-a510-c7735a922150.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1235996	ColdSpot POINT RELIEF 12 % / 4 % Topical Gel	PSN	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1045442	menthol 12 % / methyl salicylate 4 % Topical Gel	PSN	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1235996	menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate]	SBD	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1045442	menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel	SCD	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1235996	Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel	SY	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1235996	Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel	SY	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1045442	menthol 12 % / methyl salicylate 4 % Topical Gel	SY	823ccf6b-f494-4ddb-9547-431c2367d65f	4
1235996	ColdSpot POINT RELIEF 12 % / 4 % Topical Gel	PSN	7013706a-3afe-430f-a510-c7735a922150	3
1045442	menthol 12 % / methyl salicylate 4 % Topical Gel	PSN	7013706a-3afe-430f-a510-c7735a922150	3
1235996	menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate]	SBD	7013706a-3afe-430f-a510-c7735a922150	3
1045442	menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel	SCD	7013706a-3afe-430f-a510-c7735a922150	3
1235996	Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel	SY	7013706a-3afe-430f-a510-c7735a922150	3
1235996	Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel	SY	7013706a-3afe-430f-a510-c7735a922150	3
1045442	menthol 12 % / methyl salicylate 4 % Topical Gel	SY	7013706a-3afe-430f-a510-c7735a922150	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51452-001-00	51452000100	5 g in 1 BOTTLE, DISPENSING	5 g	Historical
51452-001-04	51452000104	120 mL in 1 TUBE	120 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cold Spot Point Relief Pain relieving Gel - 1 Gallon	Fabrication Enterprises \| Pure Source, LLC	2019-04-09	HUMAN OTC DRUG LABEL	9
Cold Spot Point Relief Pain relieving Gel - 32 oz.	Fabrication Enterprises \| Pure Source, LLC	2019-04-09	HUMAN OTC DRUG LABEL	5
Cold Spot Point Relief Pain relieving Gel - 16 oz.	Fabrication Enterprises \| pure source	2010-10-05	HUMAN OTC DRUG LABEL	4
Cold Spot Point Relief Pain relieving Gel - 5 G	Fabrication Enterprises \| pure source	2010-10-05	HUMAN OTC DRUG LABEL	4
Cold Spot Point Relief Pain relieving Gel - 4 oz.	Fabrication Enterprises \| pure source	2010-10-05	HUMAN OTC DRUG LABEL	3