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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	Epic Medical Supply Corp	259fbfe4-d67c-ea1e-e063-6294a90a0fb0	2025-01-07	Warnings	Exact identifier application number: M017
Sinsin Mulpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	22ea8a51-fdee-4650-abf8-f996268c9303	2025-01-07	Warnings	Exact identifier application number: M017
SINSINPAP COOL	LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS	Sinsin Pharmaceutical Co., Ltd.	9d47855f-ccb5-4557-a31a-a2b336fa9806	2025-01-07	Warnings	Exact identifier application number: M017
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare Arm, Neck, Leg	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	59a104ee-7034-99c3-e053-2991aa0a164c	2025-01-06	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare 03	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	416ebf5a-2efb-6d0b-e054-00144ff88e88	2025-01-06	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll-on	MENTHOL	ADP Health Limited	e0bb77b2-45ee-45fa-9659-9c7d99bb20dc	2025-01-05	Warnings	Exact identifier application number: M017
health and beyond BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b6bb3ed-50fb-40c4-acb6-ae3f16031531	2025-01-05	Warnings	Exact identifier application number: M017
glo SKIN BEAUTY Remedy Gel	GLO SKIN BEAUTY REMEDY GEL	Hayden Caleel LLC	aa47ff08-07b3-4fd1-bae5-420e4b928f06	2025-01-05	Warnings	Exact identifier application number: M017
Capsaicin 0.025% Cream	CAPSAICIN 0.025%	Puretek Corporation	28f00df0-c416-f17b-e063-6294a90a5570	2025-01-02	Warnings	Exact identifier application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	Tai Guk Pharm. Co., Ltd.	8f29ffd7-48b9-109f-e053-2995a90ab215	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Arthritis Pain Relief Cream Capsaisin	CAPSAISIN	Tai Guk Pharm. Co., Ltd.	8f286a9d-8765-21b3-e053-2a95a90ae43a	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Exact identifier application number: M017
HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	b9d033f3-4d12-a2c8-e053-2995a90ac7f1	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief with Menthol	MENTHOL	Green Compass, Inc.	0a0c212e-ae5d-8505-e063-6394a90af622	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	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