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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DZUL - LIDO CREME	LIDOCAINE HCL, MENTHOL	Caball Sales, Inc.	063387e4-a1b1-a467-e063-6294a90a6cbd	2026-01-08	Warnings	Exact identifier application number: M017
TOPICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	7f96e980-891e-743d-e053-2a91aa0aea5f	2026-01-08	Warnings	Exact identifier application number: M017
LUBRICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	9d7416b1-607d-34e0-e053-2a95a90aa3c3	2026-01-08	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	0a1aeff0-bade-457b-a0ac-099d646c0b2e	2026-01-08	Warnings	Exact identifier application number: M017
4% MENTHOL COLD THERAPY	MENTHOL	Universal Distribution Center LLC	66892993-a755-4584-b2a8-2e8d7ac70593	2026-01-08	Warnings	Exact identifier application number: M017
Private Label Antifungal Barrier Cream	2% MICONAZOLE NITRATE CREAM	Swiss-American CDMO, LLC	e74bddea-c1ac-4e4e-84bd-5a9defb85b2d	2026-01-08	Warnings	Exact identifier application number: M017
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	e1911279-85f7-4053-b6da-8f4e991347a2	2026-01-08	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE, MENTHOL	POMG LLC	1fa980fb-fc0e-fdd0-e063-6394a90adc13	2026-01-07	Warnings	Exact identifier application number: M017
Artridon Glucosamine	MENTHOL, METHYL SALICYLATE	Pharmadel LLC	73572156-4cce-0669-e053-2991aa0aaecc	2026-01-07	Warnings	Exact identifier application number: M017
HealthWise Cooling Pain Relief	MENTHOL	Veridian Healthcare	6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd	2026-01-07	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Exact identifier application number: M017
EARTHS CARE MUSCLE AND JOINT RUB	CAMPHOR	DLC Laboratories, Inc.	71e33e06-4dc3-4ead-a122-ff89d93a64de	2026-01-07	Warnings	Exact identifier application number: M017
Amour CBD	PAIN RELIEF CREAM	SVD Premium Products	95b45e79-b1e7-17b2-e053-2995a90a8836	2026-01-07	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle	METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	845a4ead-f9c0-4009-bcae-b17cd388439b	2026-01-07	Warnings	Exact identifier application number: M017
3X Medicated Toothache and Gum Gel	BENZOCAINE	Rite Aid	996f7989-17ce-5b28-e053-2995a90af8b8	2026-01-06	Warnings	Exact identifier application number: M017
QNTAMAX Muscle and Joint Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL	Qntamax LLC	6622b94c-824e-4e84-a8d8-b60bb0b866e2	2026-01-06	Warnings	Exact identifier application number: M017
Winco Muscle and Joint Pain Relief Gel 2oz	WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF	WINCO FOODS, LLC	47bedf4e-4036-cf43-e063-6394a90a91d6	2026-01-06	Warnings	Exact identifier application number: M017
Pain Relief Hot Patch	MENTHOL AND CAPSAICIN	Universal Distribution Center LLC	110bcb16-ef0b-4bc8-8877-173a0494e1ad	2026-01-06	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	4582b4e9-0c24-069d-e063-6394a90a6f4b	2026-01-05	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