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 145 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMINO ACTIVE Topical Analgesic Cream HISTAMINE DIHYDROCHLORIDE VIREO SYSTEMS, INC. 591b1e7e-a8c0-4640-a592-4e0f3538a40e 2023-11-11 Warnings Exact identifier application number: M017 NERVE ACTIVE Pain Relief Cream MENTHOL TOP DOG DIRECT, LLC a8b85dcb-fd3e-4340-a945-609fc741443c 2023-11-11 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Arm and Neck MENTHOL Geri-Gentle Corporation e4429f70-667e-662b-e053-2a95a90a62ba 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Back MENTHOL Geri-Gentle Corporation e442b8ec-a3de-65e8-e053-2995a90af3ec 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 9f948fb4-4275-4a1f-83f8-cd708db4a296 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF PAIN RELIEF MENTHOL BLUE SPRING WELLNESS, L.L.C. b4278b70-e9a6-4d1f-bbad-257fe437b86a 2023-11-10 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort Cream with Pain Relief MENTHOL, CAPSAICIN BLUE SPRING WELLNESS, L.L.C. 2f9cf514-48be-49ec-b424-0b228b4b874a 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 1231ddd2-7661-45b2-ab15-32f7fdc078a8 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE Stuff Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 7779b26b-ae3b-4639-a6b0-826c7ab37a86 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4 2023-11-10 Warnings Exact identifier application number: M017 SUPER BLUE STUFF Pain Relief Cream MENTHOL BLUE SPRING WELLNESS, L.L.C. 066a2106-2e25-4df6-9a8d-4417ba190205 2023-11-10 Warnings Exact identifier application number: M017 INVIGO FLEX Pain Relief Gel MENTHOL WYNNPHARM INC. 909e1d8c-c517-4d6a-8682-894f042c00f8 2023-11-10 Warnings Exact identifier application number: M017 ARNIMAX Penetrating Pain Relief Gel MENTHOL WYNNPHARM INC. 3a31f805-19c6-4036-a663-ebef9b212007 2023-11-10 Warnings Exact identifier application number: M017 KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Exact identifier application number: M017 ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions da004500-5e48-487b-b96f-520a3094096c 2023-11-10 Warnings Exact identifier application number: M017 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE Rexall Sundown, LLC 55c55f1c-d2b3-6363-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 NEUROFLEX Topical Pain Relieving Liquid CAMPHOR (SYNTHETIC), MENTHOL Almark Products Inc 6da3aa84-7a01-4041-8792-a4bbf49e6e4e 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR 60-second Pain Relief CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 3b74b542-202f-469e-8025-4372e95e6b01 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f8b8d1-a20b-54b0-e054-00144ff88e88 2023-11-10 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