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 112 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join QC Cool and Heat Roll-On MENTHOL 16% Chain Drug Marketing Association Inc d35e9dfa-8a28-fdb3-e053-2995a90abc52 2024-12-15 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving MENTHOL 16% Meijer bec62df3-06c9-a115-e053-2995a90a4267 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief MENTHOL 16% Tommie Copper, Inc. b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8 2024-12-15 Warnings Exact identifier application number: M017 Pain Relief Liquid Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. c9f0447e-de43-16a5-e053-2995a90a05c1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Maximum Strength TROLAMINE SALICYLATE 10% Tommie Copper, Inc. b622c14f-9bf3-0bbd-e053-2a95a90a2adc 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. c94d00f9-42ce-1d43-e053-2a95a90a058d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b6c3d6eb-b485-33b8-e053-2a95a90a41e1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b4cd4fed-e8c8-db85-e053-2995a90a708b 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief Liquid MENTHOL 16% Tommie Copper, Inc. c93a0139-953b-5523-e053-2a95a90a0b2d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. ca011b03-a263-1908-e053-2995a90ad970 2024-12-15 Warnings Exact identifier application number: M017 Warrior Chiggerex Relief BENZOCAINE 10% Derma Care Research Labs, LLC dcf2f52b-2295-58e5-e053-2995a90a7fd8 2024-12-15 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN Trifecta Pharmaceuticals USA LLC def8d341-06a7-0e9b-e053-2995a90a0ad6 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Original CAMPHOR, MENTHOL The Mentholatum Company 19e4b812-67c6-49fd-833a-b432100363f5 2024-12-13 Warnings Exact identifier application number: M017 Cold and Hot Medicated MENTHOL The Mentholatum Company 85bf425d-59d7-4462-ba46-292145460099 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Ice LIDOCAINE HCL, MENTHOL The Mentholatum Company 4d74cbab-31cd-4579-9360-6852ee215b5e 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Deep Heating Rub Extra Strength MENTHOL, METHYL SALICYLATE The Mentholatum Company f5684158-0d83-4031-b493-5422ddc73e78 2024-12-13 Warnings Exact identifier application number: M017 Discount Drug Mart Anti-Itch CAMPHOR, MENTHOL Discount Drug Mart 87d379da-103a-c751-e053-2995a90a56de 2024-12-13 Warnings Exact identifier application number: M017 Audiologist Anti-itch HYDROCORTISONE OAKTREE PRODUCTS, INC. 853e078e-1e91-d55f-e053-2991aa0a6dcd 2024-12-13 Warnings Exact identifier application number: M017 CVS Anti itch HYDROCORTISONE CVS 884df604-711b-4a3d-e053-2995a90a3a04 2024-12-13 Warnings Exact identifier application number: M017 Dermoplast Pain Relieving BENZOCAINE AND LEVOMENTHOL Advantice Health, LLC 2347f0b8-d463-422d-8583-65624d9a1a91 2024-12-12 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