Ice Quake

Product NDC: 53113-266
11-digit product format: 531130266
Labeler code: 53113
Product ID: 53113-266_f7c673c3-0b90-48b7-8b40-39179f3b79d8
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl Salicylate, Menthol, Camphor
Dosage form: GEL
Route: TOPICAL
Labeler: Gadal Laboratories Inc
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-01-01
Marketing end: 0000-00-00
Substance: MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)
Active strength: 10 g/100g; g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53113-266		I	Inactivated by FDA		2026-10-05
excluded package	package	53113-266	53113-266-04	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 1 · 44 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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`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	53113-266-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53113-266-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53113-266-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53113-266-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53113-266-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53113-266-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53113-266-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53113-266-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53113-266-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53113-266-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53113-266-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53113-266-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53113-266-04	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53113-266-04	`110d247fa046…`	`a55b01930146…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
53113-266-04	2019-11-27	C162847	48780-1	9855d018-dcb2-cd31-e053-dbdaa90ab51a	2a7af445-83f2-4da3-8df0-51bd808f8612

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53113-266-04	Ice QuakePlus	113 g in 1 TUBE	GEL	113		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	F68VH75CJC	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
HYPROMELLOSE 2910 (10000 MPA.S)	INACTIVE INGREDIENT	0HO1H52958	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53113-266	ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [GADAL LABORATORIES INC]	1	Legacy NDC, 1 package rows	20130928_2a7af445-83f2-4da3-8df0-51bd808f8612.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1438765	camphor 3.1 % / menthol 10 % / methyl salicylate 10 % Topical Gel	PSN	2a7af445-83f2-4da3-8df0-51bd808f8612	1
1438765	camphor 0.031 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.1 MG/MG Topical Gel	SCD	2a7af445-83f2-4da3-8df0-51bd808f8612	1
1438765	camphor 3.1 % / methyl salicylate 10 % / menthol 10 % Topical Gel	SY	2a7af445-83f2-4da3-8df0-51bd808f8612	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53113-266-04	53113026604	113 g in 1 TUBE	113 g	Historical