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 119 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Kroger Company fc1677f2-4078-4ebd-9c3b-86a29a35b489 2024-11-12 Warnings Exact identifier application number: M017 CVS Health Lidocaine Cream LIDOCAINE CVS Health ad950680-c03c-4fa5-aa7f-239a889cd097 2024-11-12 Warnings Exact identifier application number: M017 CVS Arthritis Pain Relief ARTHRITIS PAIN RELIEF CVS Health 575dd514-fd99-4e44-8fc8-52938f9abc26 2024-11-11 Warnings Exact identifier application number: M017 ThermaPatch (TM) Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 26769590-cd50-1b01-e063-6394a90a445c 2024-11-09 Warnings Exact identifier application number: M017 DG Health Cold Zone Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 22594ab8-9a4a-426f-aced-5c636620fa2c 2024-11-08 Warnings Exact identifier application number: M017 Peviderm Pramoxine Hydrocholride 1% PRAMOXINE HYDROCHLORIDE Stratus Pharmaceuticals Inc 680b40fa-1922-443a-a4b0-7c3f6a2b847d 2024-11-07 Warnings Exact identifier application number: M017 Meijer Analgesic with Aloe Topical Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc f6c1e09e-4c61-4c2a-87d7-b052ed36fcac 2024-11-07 Warnings Exact identifier application number: M017 Meijer Pain Relieving Balm Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc 1b7535cc-01ac-49f0-9889-dd14b254d4ae 2024-11-07 Warnings Exact identifier application number: M017 BENGAY Tropical Jasmine LIDOCAINE Kenvue Brands LLC c416320a-c0d7-401e-b0fa-44114d76a557 2024-11-06 Warnings Exact identifier application number: M017 Bengay Ultra Strength Large Size MENTHOL, UNSPECIFIED FORM Kenvue Brands LLC f57ccc33-400b-4401-a348-c54d1eb9f5d0 2024-11-06 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing To Go BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d5749cba-32f3-cf9c-e053-2a95a90a4416 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 26473383-282c-fb10-e063-6394a90a5fa2 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 1b6f929a-db65-8a02-e063-6394a90a8b59 2024-11-06 Warnings Exact identifier application number: M017 Meijer Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc bd6f04f9-a23b-45f6-bce2-1ef7203198e1 2024-11-06 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving Analgesic LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 6d356563-9098-4994-8ad8-819a8033a9f4 2024-11-06 Warnings Exact identifier application number: M017 TopCare Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Topco Associates LLC dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab 2024-11-05 Warnings Exact identifier application number: M017 Aveeno Restorative Skin Therapy Itch Relief Balm PRAMOXINE HYDROCHLORIDE Kenvue Brands LLC 61824ca7-a2d3-4830-b2bb-149a3222bfc8 2024-11-05 Warnings Exact identifier application number: M017 Aveeno Hydrocortisone ANTI-ITCH HYDROCORTISONE Kenvue Brands LLC 233de4d7-e533-40cd-a5ed-e8b09abc626e 2024-11-05 Warnings Exact identifier application number: M017 STING MASTER LIDOCAINE HYDROCHLORIDE Les Technologies Ptero, Inc 94c6fd1f-9e74-420b-9d25-61b37953b838 2024-11-05 Warnings Exact identifier application number: M017 Alocane Emergency Burn LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 2024-11-05 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