KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF

Product NDC: 43493-0010
11-digit product format: 434930010
Labeler code: 43493
Product ID: 43493-0010_40a7d5ab-0023-267f-e063-6394a90a4c14
Type: HUMAN OTC DRUG
Nonproprietary name: methyl salicylate, menthol, camphor
Dosage form: LIQUID
Route: TOPICAL
Labeler: Avaria Health & Beauty Corp
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-10
Substance: METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL)
Active strength: 15; 8; 3 g/100mL; g/100mL; g/100mL
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 product	product	43493-0010		D	Discontinued by firm		2026-10-12
excluded package	package	43493-0010	43493-0010-1	D	Discontinued by firm		2026-10-12

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, 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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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	43493-0010-1	`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: KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	15 g/100mL
MENTHOL	8 g/100mL
CAMPHOR (NATURAL)	3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
N20HL7Q941	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2629983	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
e0c9f22a-165a-4558-ba3c-8592f1bd0016	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43493-0010-0	KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF	1 in 1 BOX	LIQUID	1		3
43493-0010-0	KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF	80 mL in 1 BOTTLE, SPRAY	LIQUID	80		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43493-0010	KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAMPHOR) LIQUID [AVARIA HEALTH & BEAUTY CORP]	2	Current NDC, 2 package rows	20241121_e0c9f22a-165a-4558-ba3c-8592f1bd0016.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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Menthol	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	3f2b1f48-2d78-4985-a046-9f72de5e1a9b	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	10a8face-47da-ebbe-e063-6294a90a42fe	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foot Cream	MENTHOL	Reckitt Benckiser LLC	32450cbf-4ed4-402b-a30e-e08a17bba3fb	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	a227213b-e89f-7144-e053-2a95a90a7e74	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	00bb462a-27d0-6f74-e063-6394a90a90ec	2026-05-13	Warnings	Exact identifier application number: M017
BioFreeze Dry Stick	MENTHOL	Reckitt Benckiser LLC	26d62cd2-9209-8cca-e063-6394a90a2028	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foot Pain Relief Set	MENTHOL	Reckitt Benckiser LLC	4a885eef-0364-4655-bccc-7158c76cc5b2	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Colorless Roll-On	MENTHOL	Reckitt Benckiser LLC	a8d59d45-0e85-43d1-affd-bbe922c4acb1	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Colorless	MENTHOL	Reckitt Benckiser LLC	939dbbc3-71ec-4990-840e-7c9b8d430562	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Flexible Relief Strip	MENTHOL	Reckitt Benckiser LLC	6ec26bae-e395-49aa-969e-8c653d6f0b27	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Day and Overnight	MENTHOL	Reckitt Benckiser LLC	fb5c8f89-a720-ad32-e053-6294a90a2abe	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Foam	MENTHOL	Reckitt Benckiser LLC	890191e8-99ad-489c-8f21-2592f3d31936	2026-05-13	Warnings	Exact identifier application number: M017
Orajel Cold Sore Touch Free - Single Dose	BENZALKONIUM CHLORIDE, BENZOCAINE	Church & Dwight Co., Inc.	ce40829e-941f-2548-e053-2995a90a1e0e	2026-05-13	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	51b7753b-8619-6ea9-e063-6294a90a4ea4	2026-05-13	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch Cream	HYDROCORTISONE1% ANTI-ITCH CREAM	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	519c319a-9c43-0e63-e063-6394a90ab869	2026-05-13	Warnings	Exact identifier application number: M017
Valtrum TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	Laboratorios Quantium LLC	f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser	4639201c-a67a-475f-8df6-3dc6225803ad	2026-05-12	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	bae9946a-4c68-4759-9fb3-0a61a7ad0eb7	2026-05-12	Warnings	Exact identifier application number: M017
Instaflex Pain Relief Cream	MENTHOL	Healthy Directions, LLC	665b847a-9cfb-49fc-975b-81c97f936575	2026-05-12	Warnings	Exact identifier application number: M017
Theracare Cold Therapy Pain Relief	MENTHOL	Veridian Healthcare	51a5a043-07b6-1c96-e063-6394a90aa926	2026-05-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2629983	camphor 3 % / menthol 8 % / methyl salicylate 15 % Topical Foam	PSN	e0c9f22a-165a-4558-ba3c-8592f1bd0016	3
2629983	camphor 30 MG/ML / menthol 80 MG/ML / methyl salicylate 150 MG/ML Topical Foam	SCD	e0c9f22a-165a-4558-ba3c-8592f1bd0016	3
2629983	camphor 3 % / menthol 8 % / methyl salicylate 15 % Topical Foam	SY	e0c9f22a-165a-4558-ba3c-8592f1bd0016	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
43493-0010-0	43493001000	1 BOTTLE, SPRAY in 1 BOX (43493-0010-0) / 80 mL in 1 BOTTLE, SPRAY	2023-02-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF - Avaria Health & Beauty Corp	Avaria Health & Beauty Corp	2025-10-08	HUMAN OTC DRUG LABEL	3