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 59 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc 7d4e21d1-2914-4690-9084-a52abeab0958 2025-12-02 Warnings Exact identifier application number: M017 Rugby Capsaicin Cream CAPSAICIN Rugby Laboratories 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9 2025-12-02 Warnings Exact identifier application number: M017 Leader Capsaicin Pain Relief Cream CAPSAICIN Cardinal Health 110 dba LEADER a5620709-0fed-4979-e053-2a95a90ac654 2025-12-02 Warnings Exact identifier application number: M017 Hydrocortisone Acetate Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE Sun Pharmaceutical Industries, Inc. 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 2025-12-02 Warnings Exact identifier application number: M017 POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Exact identifier application number: M017 Thermacare Max Strength Lidocaine THERMACARE MAX STRENGTH LIDOCAINE Clarion Brands LLC 44fed887-d1e0-d205-e063-6294a90ac416 2025-12-02 Warnings Exact identifier application number: M017 SUNSET COOLING PAIN RELIEF ROLL-ON MENTHOL SUNSET NOVELTIES, INC 45037bc1-aa03-11ae-e063-6294a90a6c96 2025-12-02 Warnings Exact identifier application number: M017 SUNSET HEATING PAIN RELIEF ROLL-ON CAMPHOR SUNSET NOVELTIES, INC 45048936-f3c9-25f7-e063-6394a90ac4a9 2025-12-02 Warnings Exact identifier application number: M017 CAREALL Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM New World Imports, Inc 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 2025-12-01 Warnings Exact identifier application number: M017 CareALL Arthritis and Muscle CAPSAICIN New World Imports, Inc 4867eac4-00ea-434e-b289-1c1ef0342c23 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc cba7c084-379f-4a16-aeba-b11ca6e20d8a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc d066002d-8ceb-4d16-9744-d5ca25d2ad5a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 013beea4-b2c2-4e84-b4cb-3125ac48e8c0 2025-12-01 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN A2A Integrated Pharmaceuticals, LLC 147f3594-7362-7a78-e063-6294a90a3e42 2025-11-30 Warnings Exact identifier application number: M017 Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Exact identifier application number: M017 Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Exact identifier application number: M017 Itch Relief ITCH RELIEF GEL Neilmed Pharmaceuticals Inc. 44811828-c32e-17fc-e063-6294a90add48 2025-11-26 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON Clarion Brands LLC 4482d34d-eaca-5522-e063-6394a90a6afb 2025-11-26 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