FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
AMRUTANJAN RELIEF STRONG PAIN BALM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.15 g/g
METHYL SALICYLATE.15 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, LAV5U5022Y
Rxcui1599818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53554-020-05AMRUTANJAN RELIEF STRONG PAIN BALM1 in 1 CARTONOINTMENT116
53554-020-05AMRUTANJAN RELIEF STRONG PAIN BALM30 g in 1 JAROINTMENT3016
53554-020-06AMRUTANJAN RELIEF STRONG PAIN BALM30 g in 1 BOTTLE, GLASSOINTMENT3016
53554-020-06AMRUTANJAN RELIEF STRONG PAIN BALM1 in 1 CARTONOINTMENT116
53554-020-10AMRUTANJAN RELIEF STRONG PAIN BALM1 in 1 CARTONOINTMENT116
53554-020-10AMRUTANJAN RELIEF STRONG PAIN BALM50 g in 1 JAROINTMENT5016
53554-020-11AMRUTANJAN RELIEF STRONG PAIN BALM1 in 1 CARTONOINTMENT116
53554-020-11AMRUTANJAN RELIEF STRONG PAIN BALM50 g in 1 BOTTLE, GLASSOINTMENT5016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
MENTHOLACTIVE MOIETYL7T10EIP3AAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UAMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53554-020AMRUTANJAN RELIEF STRONG PAIN BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]15Current NDC, Legacy NDC, 8 package rows20250501_206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599818menthol 15 % / methyl salicylate 15 % Topical OintmentPSN206d8c1e-eb5b-4ec7-a54e-8defc9fb9d2716
1599818menthol 0.15 MG/MG / methyl salicylate 0.15 MG/MG Topical OintmentSCD206d8c1e-eb5b-4ec7-a54e-8defc9fb9d2716
1599818menthol 15 % / methyl salicylate 15 % Topical OintmentSY206d8c1e-eb5b-4ec7-a54e-8defc9fb9d2716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53554-020-03535540020031 JAR in 1 BLISTER PACK (53554-020-03) > 9 g in 1 JAR1 jar2020-12-220000-00-00NoNoCurrent
53554-020-05535540020051 JAR in 1 CARTON (53554-020-05) / 30 g in 1 JAR1 jar2025-05-010000-00-00NoNoCurrent
53554-020-06535540020061 BOTTLE, GLASS in 1 CARTON (53554-020-06) / 30 g in 1 BOTTLE, GLASS2025-05-01NoNoCurrent
53554-020-10535540020101 JAR in 1 CARTON (53554-020-10) / 50 g in 1 JAR1 jar2025-05-010000-00-00NoNoCurrent
53554-020-11535540020111 BOTTLE, GLASS in 1 CARTON (53554-020-11) / 50 g in 1 BOTTLE, GLASS2025-05-01NoNoCurrent