AMRUTANJAN RELIEF PAIN BALM

Product NDC
53554-010
Requested package NDC
53554-010-10
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

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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
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
1648512Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ddee6714-8b18-4d87-944b-8467fda22e6bAvailable on FDA.report

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

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 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017

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
53554-010-10535540010101 JAR in 1 CARTON (53554-010-10) / 50 g in 1 JAR1 jar2025-07-220000-00-00NoNoCurrent