FDA.reportPublic FDA data

AMRUTANJAN RELIEF PAIN BALM

Product NDC
53554-010
11-digit product format
535540010
Labeler code
53554
Product ID
53554-010_8b03649c-51ba-49cc-810f-244365f6656c
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR , MENTHOL, METHYL SALICYLATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
AMRUTANJAN HEALTH CARE LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-22
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.1; .08; .14 g/g; 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 PAIN BALM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).1 g/g
MENTHOL, UNSPECIFIED FORM.08 g/g
METHYL SALICYLATE.14 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui1648512

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53554-010-03AMRUTANJAN RELIEF PAIN BALM1 in 1 BLISTER PACKOINTMENT114
53554-010-03AMRUTANJAN RELIEF PAIN BALM9 g in 1 JAROINTMENT914
53554-010-05AMRUTANJAN RELIEF PAIN BALM1 in 1 CARTONOINTMENT114
53554-010-05AMRUTANJAN RELIEF PAIN BALM30 g in 1 JAROINTMENT3014
53554-010-06AMRUTANJAN RELIEF PAIN BALM30 g in 1 BOTTLE, GLASSOINTMENT3014
53554-010-06AMRUTANJAN RELIEF PAIN BALM1 in 1 CARTONOINTMENT114
53554-010-10AMRUTANJAN RELIEF PAIN BALM1 in 1 CARTONOINTMENT114
53554-010-10AMRUTANJAN RELIEF PAIN BALM50 g in 1 JAROINTMENT5014
53554-010-11AMRUTANJAN RELIEF PAIN BALM1 in 1 CARTONOINTMENT114
53554-010-11AMRUTANJAN RELIEF PAIN BALM50 g in 1 BOTTLE, GLASSOINTMENT5014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
MENTHOLACTIVE INGREDIENTL7T10EIP3AAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
MENTHOLACTIVE MOIETYL7T10EIP3AAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
CINNAMON LEAF OILINACTIVE INGREDIENTS92U8SQ71VAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D0AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
CLOVE OILINACTIVE INGREDIENT578389D6D0AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
D&C YELLOW NO. 11INACTIVE INGREDIENT44F3HYL954AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
EAST INDIAN LEMONGRASS OILINACTIVE INGREDIENTUP0M8M3VZWAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662AMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UAMRUTANJAN RELIEF PAIN BALM (CAMPHOR , MENTHOL, METHYL SALICYLATE) OINTMENT [AMRUTANJAN HEALTH CARE LIMITED]4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648512camphor 10 % / menthol 8 % / methyl salicylate 14 % Topical OintmentPSNddee6714-8b18-4d87-944b-8467fda22e6b14
1648512camphor 0.1 MG/MG / menthol 0.08 MG/MG / methyl salicylate 0.14 MG/MG Topical OintmentSCDddee6714-8b18-4d87-944b-8467fda22e6b14
1648512camphor 10 % / menthol 8 % / methyl salicylate 14 % Topical OintmentSYddee6714-8b18-4d87-944b-8467fda22e6b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53554-010-03535540010031 JAR in 1 BLISTER PACK (53554-010-03) / 9 g in 1 JAR1 jar2025-07-220000-00-00NoNoCurrent
53554-010-05535540010051 JAR in 1 CARTON (53554-010-05) / 30 g in 1 JAR1 jar2025-07-220000-00-00NoNoCurrent
53554-010-06535540010061 BOTTLE, GLASS in 1 CARTON (53554-010-06) / 30 g in 1 BOTTLE, GLASS2025-07-22NoNoCurrent
53554-010-10535540010101 JAR in 1 CARTON (53554-010-10) / 50 g in 1 JAR1 jar2025-07-220000-00-00NoNoCurrent
53554-010-11535540010111 BOTTLE, GLASS in 1 CARTON (53554-010-11) / 50 g in 1 BOTTLE, GLASS2025-07-22NoNoCurrent