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 100 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Exact identifier application number: M017 CheeZheng Pain Relieveing Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd. abcebdf1-9037-4094-93e1-ce8f20b18ea7 2025-02-11 Warnings Exact identifier application number: M017 Tibetree Pain Relieveing Medicated Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 4216bd48-5c62-4e87-adcc-67bf7152d64d 2025-02-11 Warnings Exact identifier application number: M017 AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 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