Muscle Rub

Product NDC: 45802-174
11-digit product format: 458020174
Labeler code: 45802
Product ID: 45802-174_04ef342d-042e-42c9-a400-0ad2549a3e72
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Methyl salicylate
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-03-03
Marketing end: 0000-00-00
Substance: MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength: 10 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45802-174		D	Discontinued by firm		2026-08-07
excluded package	package	45802-174	45802-174-53	D	Discontinued by firm		2026-08-07

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45802-174-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45802-174-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45802-174-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45802-174-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45802-174-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45802-174-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45802-174-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45802-174-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45802-174-53	`0efc9e666f02…`	`f202fb6c5f17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-174-53	Varophen	85 g in 1 TUBE	CREAM	85 g	15 g in 100g	5
45802-174-53	Varophen	1 in 1 CARTON	CREAM		10 g in 100g	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-174-53	GM - Gram	45802-174	fbd45582-802b-485a-a7f5-88e7055fe672	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-174	VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]	5	Legacy NDC	20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857700	diclofenac sodium 1.5 % Topical Solution	PSN	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 % / methyl salicylate 15 % Topical Cream	PSN	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 % / methyl salicylate 15 % Topical Cream	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical Cream	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-174-53	45802017453	1 TUBE in 1 CARTON (45802-174-53) > 85 g in 1 TUBE	1 tube	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Varophen	V2 Pharma, LLC \| Apotex Inc \| Perrigo New York Inc	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	5
Perrigo Muscle Rub Drug Facts	Padagis Israel Pharmaceuticals Ltd	2024-10-28	HUMAN OTC DRUG LABEL	5
Perrigo Muscle Rub Drug Facts	Preferred Pharmaceuticals Inc.	2024-07-22	HUMAN OTC DRUG LABEL	8
Perrigo Muscle Rub Drug Facts	NuCare Pharmaceuticals,Inc.	2024-07-15	HUMAN OTC DRUG LABEL	6
Perrigo Muscle Rub Drug Facts	St. Mary's Medical Park Pharmacy	2023-12-18	HUMAN OTC DRUG LABEL	3