AMRUTANJAN RELIEF STRONG PAIN BALM

Product NDC: 53554-020
11-digit product format: 535540020
Labeler code: 53554
Product ID: 53554-020_73770c61-9c7e-466f-8371-4ad6f652cbb4
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, METHYL SALICYLATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: AMRUTANJAN HEALTH CARE LIMITED
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-01
Substance: MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength: .15; .15 g/g; g/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 40 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
2025-04-01 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	53554-020-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53554-020-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53554-020-05	`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	53554-020-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53554-020-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53554-020-05	`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	53554-020-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53554-020-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53554-020-05	`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	53554-020-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53554-020-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53554-020-05	`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	53554-020-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53554-020-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53554-020-05	`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	53554-020-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53554-020-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53554-020-05	`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	53554-020-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53554-020-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53554-020-05	`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	53554-020-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53554-020-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53554-020-05	`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	53554-020-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53554-020-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53554-020-05	`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	53554-020-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53554-020-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53554-020-05	`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: AMRUTANJAN RELIEF STRONG PAIN BALM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	.15 g/g
METHYL SALICYLATE	.15 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1599818	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
206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53554-020-05	AMRUTANJAN RELIEF STRONG PAIN BALM	1 in 1 CARTON	OINTMENT	1	16
53554-020-05	AMRUTANJAN RELIEF STRONG PAIN BALM	30 g in 1 JAR	OINTMENT	30	16
53554-020-06	AMRUTANJAN RELIEF STRONG PAIN BALM	30 g in 1 BOTTLE, GLASS	OINTMENT	30	16
53554-020-06	AMRUTANJAN RELIEF STRONG PAIN BALM	1 in 1 CARTON	OINTMENT	1	16
53554-020-10	AMRUTANJAN RELIEF STRONG PAIN BALM	1 in 1 CARTON	OINTMENT	1	16
53554-020-10	AMRUTANJAN RELIEF STRONG PAIN BALM	50 g in 1 JAR	OINTMENT	50	16
53554-020-11	AMRUTANJAN RELIEF STRONG PAIN BALM	1 in 1 CARTON	OINTMENT	1	16
53554-020-11	AMRUTANJAN RELIEF STRONG PAIN BALM	50 g in 1 BOTTLE, GLASS	OINTMENT	50	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53554-020	AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	15	Current NDC, Legacy NDC, 8 package rows	20250501_206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27.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 46 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 4% Topical Anesthetic Cream	LIDOCAINE 4%	Oncor Pharmaceuticals	1baaa669-05af-4024-a0ba-ee3451756f6a	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	6834a6de-4d1d-4e40-945d-ec5c267abd14	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	ee8cd550-64ee-432e-98e5-b68083179a3c	2026-01-05	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	0eee554f-dfe0-433a-9665-8bdb95229888	2026-01-05	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	PAIN WIZARD LIMITED LIABILITY COMPANY	2647bba1-87f4-3c16-e063-6394a90ae0c9	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	efddd116-d753-425a-9ded-09b8045024e4	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Original Menthol	MENTHOL	Veridian Healthcare	ea56e4e1-a758-428b-8758-ee31bb00ca82	2026-01-05	Warnings	Exact identifier application number: M017
Mugwort Patch (Cervical spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e220c-0d35-9ee0-e063-6294a90ab689	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Lumbar spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e4b21-6d81-4cd3-e063-6394a90a18fe	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Knee use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e86d2-3030-91eb-e063-6394a90a4db0	2026-01-04	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	4a543f90-d43c-4487-b27e-f43394c6320d	2026-01-04	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8	2026-01-02	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel Roll-On	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	bf47acb2-6c90-4d5c-820b-447cac9305a4	2026-01-02	Warnings	Exact identifier application number: M017
Amino Rip Muscle Pain Relief	LIDOCAINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2bed5764-4217-4aa3-9d90-3b5460dcffa3	2026-01-02	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	63bb0283-cfbe-4e9c-8772-73062c0c8d05	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Village Pharma LLC	4c979a71-7c8f-4dff-abae-bf4cdf8f67b4	2026-01-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma LLC	ffb7831f-4ca9-4d73-8303-e9cd90078982	2026-01-01	Warnings	Exact identifier application number: M017
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co.,Ltd.	116ee6dc-9c49-2e11-e063-6394a90a44ed	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13	2026-01-01	Warnings	Exact identifier application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVING	MENTHOL	JC SALES	5adf457e-b4d0-30c8-e063-6294a90a64b9	2026-01-01	Warnings	Exact identifier application number: M017

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
1599818	menthol 15 % / methyl salicylate 15 % Topical Ointment	PSN	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	16
1599818	menthol 0.15 MG/MG / methyl salicylate 0.15 MG/MG Topical Ointment	SCD	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	16
1599818	menthol 15 % / methyl salicylate 15 % Topical Ointment	SY	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53554-020-03	53554002003	1 JAR in 1 BLISTER PACK (53554-020-03) > 9 g in 1 JAR	1 jar	2020-12-22	0000-00-00	No	No	Current
53554-020-05	53554002005	1 JAR in 1 CARTON (53554-020-05) / 30 g in 1 JAR	1 jar	2025-05-01	0000-00-00	No	No	Current
53554-020-06	53554002006	1 BOTTLE, GLASS in 1 CARTON (53554-020-06) / 30 g in 1 BOTTLE, GLASS		2025-05-01		No	No	Current
53554-020-10	53554002010	1 JAR in 1 CARTON (53554-020-10) / 50 g in 1 JAR	1 jar	2025-05-01	0000-00-00	No	No	Current
53554-020-11	53554002011	1 BOTTLE, GLASS in 1 CARTON (53554-020-11) / 50 g in 1 BOTTLE, GLASS		2025-05-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amrutanjan Relief Strong Pain Balm ™	AMRUTANJAN HEALTH CARE LIMITED	2025-07-22	HUMAN OTC DRUG LABEL	16