FDA.reportPublic FDA data

AMRUTANJAN RELIEF PAIN BALM

Product NDC
53554-010
Requested package NDC
53554-010-03
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…

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 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 157 · 3,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
FREEZE EASEMENTHOL 4%Global America Group LLC16553eda-ec34-485a-a11c-f51260efd9fa2026-09-03WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact 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
53554-010-03535540010031 JAR in 1 BLISTER PACK (53554-010-03) / 9 g in 1 JAR1 jar2025-07-220000-00-00NoNoCurrent