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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53554-020-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53554-020-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53554-020-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53554-020-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53554-020-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53554-020-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53554-020-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53554-020-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53554-020-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53554-020-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53554-020-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53554-020-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53554-020-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53554-020-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53554-020-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53554-020-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53554-020-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53554-020-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53554-020-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53554-020-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53554-020-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53554-020-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53554-020-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53554-020-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53554-020-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53554-020-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53554-020-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53554-020-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53554-020-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53554-020-05557ba5c1ecfa…9c80585c8c6e…

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
IngredientStrength
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
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599818Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27Available on FDA.report

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#

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

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 116 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Cream Platinum 4% LidocaineLIDOCAINE 4%Telebrands Corp2788189e-35bc-d48c-e063-6294a90ae6c22024-11-21WarningsExact identifier
application number: M017
Family Wellness Ultra Strength Muscle RubULTRA STRENGTH MUSCLE RUBFAMILY DOLLAR (Family Wellness)554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a2024-11-21WarningsExact identifier
application number: M017
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
application number: M017
Family Wellness Hot and Cold Pain ReliefHOT AND COLD PAIN RELIEFFAMILY DOLLAR (Family Wellness)b70e343b-18aa-4e45-ae8e-79d8c84ad2052024-11-21WarningsExact identifier
application number: M017
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
application number: M017
WINCO HydrocortisoneHYDROCORTISONE 1%WinCo Foods LLC26a29de3-4b79-4a3a-93b6-a14c5e91a8c62024-11-21WarningsExact identifier
application number: M017
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEDynarex Corporationd0e43651-4215-465b-9ace-1bc23126b1092024-11-20WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain Relief Gel-PatchMENTHOLTelebrands Corp976a1bb2-b776-8199-e053-2995a90a1a1b2024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain ReliefTROLAMINE SALICYLATETELEBRANDS CORPd91a0fad-a38c-1580-e053-2a95a90ad2682024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief - PlatinumTROLAMINE SALICYLATETELEBRANDS CORPd58da6c5-47a6-b8a8-e053-2995a90a7ce72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPdf5d3312-cbc5-5db9-e053-2995a90ab0552024-11-20WarningsExact identifier
application number: M017
Hempvana Cold as Ice GelMENTHOLTelebrands Corpa9e103f2-778f-e49b-e053-2a95a90aa8b72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPd58e2c47-c0f4-625e-e053-2a95a90aa4d52024-11-20WarningsExact identifier
application number: M017
Hempvana Pain ReliefTROLAMINE SALICYLATETelebrands Corp92a29553-a102-0a0e-e053-2a95a90ab24a2024-11-20WarningsExact identifier
application number: M017
Ultra Strength Pain Relief GelMENTHOLTELEBRANDS CORPd91b2e09-550e-4968-e053-2995a90ae3232024-11-20WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief CreamLIDOCAINE 4%Telebrands Corpc3162ba8-ac2d-5a65-e053-2995a90af2462024-11-20WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain ReliefLIDOCAINETELEBRANDS CORPd91ba9b1-083f-32e9-e053-2a95a90a9bd12024-11-20WarningsExact identifier
application number: M017
DynaRubPAIN RELIEVING CREAMDynarex Corporation7f853941-a2d7-ed26-e053-2991aa0aa9ee2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsbcdc0322-bc75-4662-9c5a-d1be1d0552522024-11-20WarningsExact identifier
application number: M017

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