Home NDC 53554-020 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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 101 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC d4276749-eeff-28f7-e053-2a95a90a593d 2025-01-31 Warnings Exact identifier application number: M017 MyDerm Bite Relief BENZOCAINE Inspec Solutions LLC. 88615668-16b5-7840-e053-2a95a90a9208 2025-01-31 Warnings Exact identifier application number: M017 Maximum Strength Blue Emu Pain Relief Blu Emu TROLAMINE SALICYLATE Kingsway Pharmaceuticals dba NFI, LLC 5e02b820-e53a-42cb-abdb-2925617c29ca 2025-01-31 Warnings Exact identifier application number: M017 Sunset Novelties Herquake NUMBING LUBRICANT SUNSET INTIMATES GROUP INC 2ceeca3e-9197-9166-e063-6394a90ae908 2025-01-30 Warnings Exact identifier application number: M017 Magsoothium CBD Cooling Roll on Relief MENTHOL Ubu/Elements, Inc. 2cf05dcd-6a44-de08-e063-6394a90aaba0 2025-01-30 Warnings Exact identifier application number: M017 Meijer Vagicaine 20% BENZOCAINE AND 3% RESORCINOL CREAM Meijer, Inc. dac73a07-7569-4788-977a-f10d098da75d 2025-01-30 Warnings Exact identifier application number: M017 ZCort Ultra HYDROCORTISONE ACETATE 1% RxDino, LLC b68f8ada-58e8-e8e4-e053-2a95a90ab02d 2025-01-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relieving Gel-Patch LIDOCAINE 4% Noble OTC LLC 12a3ce63-6fce-0993-e063-6294a90a40d5 2025-01-28 Warnings Exact identifier application number: M017 INTIMALE LIDOCAINE DELAY LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 5ddd7d56-bf51-462b-afcd-944861e49781 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Relax Massage CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0eae24e-09cf-0d2d-e053-2a95a90acedc 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebbc0f-9888-b812-e053-2a95a90a5d3d 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Arthritis Aches and Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec7255-bb36-41cd-e053-2a95a90aeac4 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Back and Neck Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec8fc9-c401-5f23-e053-2995a90acb1c 2025-01-28 Warnings Exact identifier application number: M017 Muscle Therapy METHYL SALICYLATE, CAMPHOR Everlaan Organics Inc 0890a683-9a66-fdbd-e063-6294a90ae526 2025-01-27 Warnings Exact identifier application number: M017 Joint Therapy CAMPHOR Everlaan Organics Inc 08904b77-d6db-8b82-e063-6394a90ace4f 2025-01-27 Warnings Exact identifier application number: M017 Warrior Arthritis Relief TROLAMIN SALICYLATE 10% Derma Care Research Labs, LLC 013f48b9-913f-b283-e063-6394a90abd73 2025-01-27 Warnings Exact identifier application number: M017 DCH Cool and Heat MENTHOL 16% Derma Care Research Labs, LLC ff323282-612c-eaf8-e053-6394a90ab779 2025-01-27 Warnings Exact identifier application number: M017 Gerigentle HYDROCORTISONE GERI-GENTLE CORPORATION 0adfa2f0-9758-5c54-e063-6294a90a461f 2025-01-25 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pain Relieving MENTHOL, CAMPHOR Active and Innovative Inc. 42f1abeb-f6d7-01c3-e054-00144ff88e88 2025-01-23 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 53554-020-03 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