Kalaya Pain Relief 6X with Arnica

Product NDC: 43493-0003
11-digit product format: 434930003
Labeler code: 43493
Product ID: 43493-0003_40a7bf23-d766-3c50-e063-6294a90abaa0
Type: HUMAN OTC DRUG
Nonproprietary name: Pain Relief Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Avaria Health & Beauty Corp
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-01-01
Substance: METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL); EUCALYPTUS OIL
Active strength: 11; 4; 4; .5 g/100g; g/100g; g/100g; g/100g
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	43493-0003		D	Discontinued by firm		2026-10-21
excluded package	package	43493-0003	43493-0003-4	D	Discontinued by firm		2026-10-21

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 · 32 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 package	package	43493-0003-4	D	Discontinued by firm	`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 package	package	43493-0003-4	D	Discontinued by firm	`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 package	package	43493-0003-4	D	Discontinued by firm	`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 package	package	43493-0003-4	D	Discontinued by firm	`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 package	package	43493-0003-4	D	Discontinued by firm	`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 package	package	43493-0003-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43493-0003-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43493-0003-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43493-0003-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43493-0003-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43493-0003-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43493-0003-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43493-0003-4	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43493-0003-4	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43493-0003-4	Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43493-0003-4	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`

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 Pain Relief 6X with Arnica
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	11 g/100g
MENTHOL	4 g/100g
CAMPHOR (NATURAL)	4 g/100g
EUCALYPTUS OIL	.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
N20HL7Q941	Internal UNII lookup
2R04ONI662	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
60198d2e-4de3-3fa0-e053-2a91aa0afaf7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
43493-0003-4	2022-03-11	ab0e2407-3530-f274-e053-dbdaa90a6471	Kalaya Pain Relief 6X with Arnica - Sample Size (10gm, 0.35oz) in sealed plastic bag with Drug Facts Insert Card
43493-0003-1	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-1	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-2	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-2	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-3	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-3	2020-04-20	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-1	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-1	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-2	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-2	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-3	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.
43493-0003-3	2020-01-31	9d75b9cf-deb0-f424-e053-dadaa90a57ce	Avaria Kalaya- 3 package put ups. Two tubes and one roller applicator.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43493-0003-1	Kalaya Pain Relief 6X with Arnica	120 g in 1 TUBE	CREAM	120	19
43493-0003-2	Kalaya Pain Relief 6X with Arnica	50 g in 1 TUBE	CREAM	50	19
43493-0003-3	Kalaya Pain Relief 6X with Arnica	120 g in 1 BOTTLE, WITH APPLICATOR	CREAM	120	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43493-0003	KALAYA PAIN RELIEF 6X WITH ARNICA (PAIN RELIEF CREAM) CREAM [AVARIA HEALTH & BEAUTY CORP]	18	Current NDC, Legacy NDC, 3 package rows	20241024_60198d2e-4de3-3fa0-e053-2a91aa0afaf7.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 8 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	57994923-20fc-9d9d-e063-6394a90a22c9	2026-07-27	Warnings	Exact identifier application number: M017
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	579a5012-837a-828b-e063-6294a90a4fb2	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF	MENTHOL	OWELL NATURAL 8 LLC	57a124b4-66c6-2474-e063-6294a90ab0d7	2026-07-27	Warnings	Exact identifier application number: M017
Icy Hot Performance Dry	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	8927570f-761b-4d83-8612-30077224fdb8	2026-07-27	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	578675e8-30e7-6986-e063-6394a90a8afe	2026-07-26	Warnings	Exact identifier application number: M017
Do Me Delay Cream	BENZOCAINE	Prodigy Media	53d5cd6b-96b8-9ba2-e063-6294a90a0d15	2026-07-24	Warnings	Exact identifier application number: M017
Bravado Labs Delay Cream	BENZOCAINE	Prodigy Media Inc	57269544-9cfb-4ff0-e063-6394a90adb02	2026-07-24	Warnings	Exact identifier application number: M017
Zytherial Lidocaine 4% Pain Relief Patch	LIDOCAINE 4% PAIN RELIEF PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56db5028-b631-7981-e063-6294a90ae395	2026-07-24	Warnings	Exact identifier application number: M017
AEROBURN	LIDOCAINE HYDROCHLORIDE	Aero Healthcare US LLC	f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f	2026-07-24	Warnings	Exact identifier application number: M017
AEROSOOTHE	HYDROCORTISONE	Aero Healthcare US LLC	22b172a2-07e8-4ebb-b0a0-dfe4f25477fa	2026-07-24	Warnings	Exact identifier application number: M017
Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	CVS Pharmacy	49003aac-184c-ae33-e063-6294a90a29c0	2026-07-24	Warnings	Exact identifier application number: M017
Arlun Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5765fbf1-e835-a11e-e063-6394a90a5ac2	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE PAIN RELIEF	ARNICA MONTANA HPUS 7% PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4bb74112-c4e7-7988-e063-6394a90ae3f1	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4c667f3d-1238-2f02-e063-6394a90ab742	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7222b-d754-9861-e063-6294a90a1b7b	2026-07-24	Warnings	Exact identifier application number: M017
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7d0ca-6407-1fed-e063-6394a90aaccc	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID	NICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AID	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5821f9-605e-5391-e063-6294a90afcd2	2026-07-24	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)
2R04ONI662	EUCALYPTUS OIL	8000-48-4	EUCALYPTUS OIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43493-0003-1	43493000301	120 g in 1 TUBE (43493-0003-1)	120 g	2018-01-01	0000-00-00	No	No	Current
43493-0003-2	43493000302	50 g in 1 TUBE (43493-0003-2)	50 g	2018-07-01	0000-00-00	No	No	Current
43493-0003-3	43493000303	120 g in 1 BOTTLE, WITH APPLICATOR (43493-0003-3)	120 g	2018-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain Relief Cream	Avaria Health & Beauty Corp	2025-10-08	HUMAN OTC DRUG LABEL	19
Pain Relief Cream	Avaria Health & Beauty Corp.	2019-05-01	HUMAN OTC DRUG LABEL	1