Home NDC 53554-010 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.
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 133 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. 1dc21c95-b419-4175-85f8-040b73060d37 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Roll-On Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. d94ae654-ce25-4bff-b9bd-24a0e0e8568a 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. f8bff018-fb4f-47b4-b8f8-4a496aede346 2024-03-20 Warnings Exact identifier application number: M017 Rugby Arthritis Pain Relieving Topical Analgesic CAPSAICIN Rugby Laboratories 8f1bc075-97ac-4154-8768-0d878104c3ba 2024-03-14 Warnings Exact identifier application number: M017 Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM Rugby Laboratories 2b65cb6a-4364-4770-b7b9-5c4637edd01a 2024-03-14 Warnings Exact identifier application number: M017 Leader Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER fd06d17f-4dff-42a9-a84f-904809ceb981 2024-03-13 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR EROS GLOBAL b3495c95-ba4b-9459-e053-2a95a90a710f 2024-03-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 1369e70f-7a61-7078-e063-6394a90a9a88 2024-03-11 Warnings Exact identifier application number: M017 Pain Reliever Cream MENTHOL 10%, METHYL SALICYLATE 15% Trifecta Pharmaceuticals USA, LLC. 130665d6-3de8-cb91-e063-6294a90a2083 2024-03-06 Warnings Exact identifier application number: M017 Dermachange Aid Anti-Itch DIPHENHYDRAMINE HCL Private Label Beauty and Wellness 12ed906c-d028-0ff7-e063-6394a90aaa52 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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