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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ULTRA STRENGTH ZHENG GU SHUI	MENTHOL AND CAMPHOR	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	53397663-044d-4e48-989b-2c6257af5f84	2025-07-14	Warnings, Adverse reactions	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	cb60037f-bceb-4090-a5e4-bdda0cbf9f5c	2025-07-14	Warnings	Exact identifier application number: M017
Avedana Hydrocortisone Cream with Aloe	HYDROCORTISONE	Unipack LLC	2a55c426-39b4-4d94-b6b4-6c548c9685e9	2025-07-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Rite Aid Corporation	cb6e0bed-2ea1-49d2-89e7-2554e7565b74	2025-07-11	Warnings	Exact identifier application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Exact identifier application number: M017
Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	TARGET Corporation	6fba5890-f48f-4302-a8ac-5087a6e03bd5	2025-07-11	Warnings	Exact identifier application number: M017
TopCare Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	2025-07-11	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	309d9be0-e367-429a-a1fa-ab7855477c8a	2025-07-10	Warnings	Exact identifier application number: M017
Bengay Vanishing Scent	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	6cc3294b-3b0f-44d0-af71-61db1022d269	2025-07-10	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Quality Choice	ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3	2025-07-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	Warnings	Exact identifier application number: M017
CVS Cortisone	HYDROCORTISONE	CVS Pharmacy	87631be8-94b8-4718-858d-d2f30e636cce	2025-07-10	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Topco Associates LLC	c40e8e1d-d6d7-4880-99d3-011b97a5e4f3	2025-07-10	Warnings	Exact identifier application number: M017
Live Better Hydrocortisone with Aloe	HYDROCORTISONE	The Great Atlantic & Pacific Tea Company	044e6ee2-98a6-4802-b33d-78b8551356c4	2025-07-10	Warnings	Exact identifier application number: M017
Rocainol TOPICAL ANALGESIC	METHYL SALICYLATE, MENTHOL	Compania Internacional de Comercio, S.A.P.I de C.V.	827ec7b2-3d87-47e0-a47a-966b25732c32	2025-07-10	Warnings	Exact identifier application number: M017
NumbR-X	LIDOCAINE HCL	Prodigy Media Inc	16329ab6-4a33-4c38-85e0-5aad9c75d61d	2025-07-10	Warnings	Exact identifier application number: M017
Dr Lido	LIDOCAINE HCL	Prodigy Media Inc	da0938f0-00e7-4502-8721-d64c71f594fc	2025-07-10	Warnings	Exact identifier application number: M017
Pain Relief Patch	CAMPHOR, METHYL SALICYLATE, MENTHOL	CDMA, Inc.	da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b	2025-07-09	Warnings	Exact identifier application number: M017
ORTHOGEL Menthol 3.5%	MENTHOL	LiquidCapsule Manufacturing LLC	4fd4b7ac-1971-4abe-8fbb-74ab69e12061	2025-07-09	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	AmerisourceBergen	f36acdb8-a526-4bb7-a557-e1dcbbc1cf45	2025-07-08	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