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 131 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare19fe7c3b-58e2-6c16-e063-6394a90a612a2024-06-03WarningsExact identifier
application number: M017
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
application number: M017
Methyl Salicylate 25 PercentMETHYL SALICYLATEAlexso, Incd8b8b0ba-69e9-4965-bf9b-6db21db69b342024-05-23WarningsExact identifier
application number: M017
Meijer Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMeijer Distribution07ecc6a7-bbe3-35cf-e063-6394a90a21802024-05-22WarningsExact identifier
application number: M017
TheraCare Hydrocortisone CreamHYDROCORTISONEVeridian Healthcare01cb7b47-2c3c-707d-e063-6294a90a5d972024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact 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