AMRUTANJAN RELIEF PAIN BALM

Product NDC: 53554-010
11-digit product format: 535540010
Labeler code: 53554
Product ID: 53554-010_8b03649c-51ba-49cc-810f-244365f6656c
Type: HUMAN OTC DRUG
Nonproprietary name: CAMPHOR , MENTHOL, METHYL SALICYLATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: AMRUTANJAN HEALTH CARE LIMITED
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-07-22
Substance: CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength: .1; .08; .14 g/g; 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	53554-010-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53554-010-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53554-010-05	`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	53554-010-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53554-010-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53554-010-05	`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	53554-010-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53554-010-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53554-010-05	`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	53554-010-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53554-010-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53554-010-05	`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	53554-010-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53554-010-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53554-010-05	`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	53554-010-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53554-010-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53554-010-05	`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	53554-010-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53554-010-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53554-010-05	`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	53554-010-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53554-010-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53554-010-05	`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	53554-010-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53554-010-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53554-010-05	`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	53554-010-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53554-010-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53554-010-05	`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 PAIN BALM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAMPHOR (SYNTHETIC)	.1 g/g
MENTHOL, UNSPECIFIED FORM	.08 g/g
METHYL SALICYLATE	.14 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5TJD82A1ET	Internal UNII lookup
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
1648512	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
ddee6714-8b18-4d87-944b-8467fda22e6b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53554-010-03	AMRUTANJAN RELIEF PAIN BALM	1 in 1 BLISTER PACK	OINTMENT	1	14
53554-010-03	AMRUTANJAN RELIEF PAIN BALM	9 g in 1 JAR	OINTMENT	9	14
53554-010-05	AMRUTANJAN RELIEF PAIN BALM	1 in 1 CARTON	OINTMENT	1	14
53554-010-05	AMRUTANJAN RELIEF PAIN BALM	30 g in 1 JAR	OINTMENT	30	14
53554-010-06	AMRUTANJAN RELIEF PAIN BALM	30 g in 1 BOTTLE, GLASS	OINTMENT	30	14
53554-010-06	AMRUTANJAN RELIEF PAIN BALM	1 in 1 CARTON	OINTMENT	1	14
53554-010-10	AMRUTANJAN RELIEF PAIN BALM	1 in 1 CARTON	OINTMENT	1	14
53554-010-10	AMRUTANJAN RELIEF PAIN BALM	50 g in 1 JAR	OINTMENT	50	14
53554-010-11	AMRUTANJAN RELIEF PAIN BALM	1 in 1 CARTON	OINTMENT	1	14
53554-010-11	AMRUTANJAN RELIEF PAIN BALM	50 g in 1 BOTTLE, GLASS	OINTMENT	50	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
CINNAMON LEAF OIL	INACTIVE INGREDIENT	S92U8SQ71V	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
CITRONELLA OIL	INACTIVE INGREDIENT	QYO8Q067D0	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
CLOVE OIL	INACTIVE INGREDIENT	578389D6D0	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
D&C YELLOW NO. 11	INACTIVE INGREDIENT	44F3HYL954	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
EAST INDIAN LEMONGRASS OIL	INACTIVE INGREDIENT	UP0M8M3VZW	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]	4

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 84 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMRUTANJAN RELIEF PAIN BALM	CAMPHOR , MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	ddee6714-8b18-4d87-944b-8467fda22e6b	2025-07-23	Warnings	Exact identifier application number: M017 ndc (product): 53554-010
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	8bb89002-d7a2-4bee-b5a5-1fd1949273ef	2025-07-22	Warnings	Exact identifier application number: M017
Hielo Ardiente	MENTHOL	Menper Distributors, Inc.	97ec516c-d2bc-47ce-82fe-bd68445d9570	2025-07-22	Warnings	Exact identifier application number: M017
La Flecha Japonesa	METHYL SALICYLATE	Menper Distributors, Inc.	08819ad0-97c2-49bd-b923-535b94a27167	2025-07-22	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Menper Distributors Inc.	ad940dc8-9403-44cf-aed3-6e538cbe488b	2025-07-22	Warnings	Exact identifier application number: M017
Balsamo de Vaca Mascura	METHYL SALICYLATE	Menper Distributors Inc.	321b6f1f-c802-4b96-99d3-e77217da11a3	2025-07-22	Warnings	Exact identifier application number: M017
Abejas y Viboras Roll On	METHYL SALICYLATE	Menper Distributors Inc.	bedf3b36-7def-099f-e053-2a95a90ac15b	2025-07-22	Warnings	Exact identifier application number: M017
HealthWise Flexible 4% Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3869cc18-5494-6142-e063-6394a90a75e5	2025-07-22	Warnings	Exact identifier application number: M017
Arthcal 4% Lidocaine Patches	LIDOCAINE	Beijing JUNGE Technology Co., Ltd.	2e531194-67ad-c645-e063-6394a90a916c	2025-07-22	Warnings	Exact identifier application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALM	MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	2025-07-22	Warnings	Exact identifier application number: M017
Cold Sore Fast-Acting Pain Relief	GLYCERIN AND LIDOCAINE	Blistex Inc.	c7511322-dd6c-441c-bf7d-ad4f0c14956a	2025-07-22	Warnings	Exact identifier application number: M017
Mountain Ice Sports Pain Relief	MENTHOL, CAMPHOR	Mountainside Medical Equipment, Inc.	c1f5512c-67b1-4ff0-b1a5-616e883d436f	2025-07-21	Warnings	Exact identifier application number: M017
Stopain Clinical Roll-On	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	27703209-fdac-4620-a445-d89a84bc853d	2025-07-21	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Exact identifier application number: M017
Dr Kevin Khalili Pain Relief Cream	MENTHOL	DR. KHALILI LLC	3a79b38c-9adc-60dd-e063-6394a90a5b30	2025-07-21	Warnings	Exact identifier application number: M017
ARTHRITIS PAIN RELIEF	CAMPHOR, CAPSAICIN, METHYL SALICYLATE	YUNNAN BAIYAO GROUP CO., LTD.	671c57f0-3c6f-4416-bc81-f6930fef327b	2025-07-21	Warnings	Exact identifier application number: M017
GoodSense Cooling Pain Relief	MENTHOL	Geiss, Destin & Dunn, Inc	2e5e1375-df07-9a43-e063-6394a90a9938	2025-07-20	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Cooling	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a7eae5dc-9db6-4bdf-9179-76060e75e044	2025-07-18	Warnings	Exact identifier application number: M017
Nicotine Patches	NICOTINE PATCHES	Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.	3a1abd26-c0aa-8a65-e063-6294a90ab66e	2025-07-17	Warnings	Exact identifier application number: M017
Aouiv 4% Lidocaine Numbing Cream	4% LIDOCAINE NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	3a221dd2-e945-bd0e-e063-6294a90a8fb9	2025-07-17	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
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
1648512	camphor 10 % / menthol 8 % / methyl salicylate 14 % Topical Ointment	PSN	ddee6714-8b18-4d87-944b-8467fda22e6b	14
1648512	camphor 0.1 MG/MG / menthol 0.08 MG/MG / methyl salicylate 0.14 MG/MG Topical Ointment	SCD	ddee6714-8b18-4d87-944b-8467fda22e6b	14
1648512	camphor 10 % / menthol 8 % / methyl salicylate 14 % Topical Ointment	SY	ddee6714-8b18-4d87-944b-8467fda22e6b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53554-010-03	53554001003	1 JAR in 1 BLISTER PACK (53554-010-03) / 9 g in 1 JAR	1 jar	2025-07-22	0000-00-00	No	No	Current
53554-010-05	53554001005	1 JAR in 1 CARTON (53554-010-05) / 30 g in 1 JAR	1 jar	2025-07-22	0000-00-00	No	No	Current
53554-010-06	53554001006	1 BOTTLE, GLASS in 1 CARTON (53554-010-06) / 30 g in 1 BOTTLE, GLASS		2025-07-22		No	No	Current
53554-010-10	53554001010	1 JAR in 1 CARTON (53554-010-10) / 50 g in 1 JAR	1 jar	2025-07-22	0000-00-00	No	No	Current
53554-010-11	53554001011	1 BOTTLE, GLASS in 1 CARTON (53554-010-11) / 50 g in 1 BOTTLE, GLASS		2025-07-22		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amrutanjan Relief Pain Balm ™	AMRUTANJAN HEALTH CARE LIMITED	2025-07-23	HUMAN OTC DRUG LABEL	14