FDA.reportPublic FDA data

Geliga

Product NDC
60954-003
11-digit product format
609540003
Labeler code
60954
Product ID
60954-003_237b5cf3-a723-aedc-e063-6394a90af1f7
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-03
Substance
METHYL SALICYLATE; MENTHOL
Active strength
29.95; 13.5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Geliga
Brand name suffix
Muscular Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE29.95 g/100g
MENTHOL13.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2642205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da28097f-4b5c-6159-e053-2a95a90a7d96Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-003-20GeligaMuscular Balm20 g in 1 BOTTLE, GLASSOINTMENT204
60954-003-20GeligaMuscular Balm1 in 1 BOXOINTMENT14
60954-003-40GeligaMuscular Balm1 in 1 BOXOINTMENT14
60954-003-40GeligaMuscular Balm40 g in 1 BOTTLE, GLASSOINTMENT404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-003GELIGA MUSCULAR BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [PT. EAGLE INDO PHARMA]4Current NDC, 4 package rows20241004_da28097f-4b5c-6159-e053-2a95a90a7d96.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 21 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLASCLEMED USA INC.68dc0231-3364-448b-bde9-f19fa122c7652026-05-05WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
application number: M017
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
application number: M017
5Kind DMSO Pain RelievingCAMPHOR (SYNTHETIC)5Kind Trading LTD62b55114-47f4-473a-8406-78238c3c1fa22026-05-04WarningsExact identifier
application number: M017
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
application number: M017
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
application number: M017
Feminine Anti Itch CreamBENZOCAINE,RESORCINOLTRIFECTA PHARMACEUTICALS USA LLC50c3acbf-b873-908a-e063-6294a90a66b72026-05-01WarningsExact identifier
application number: M017
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
application number: M017
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsExact identifier
application number: M017
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
application number: M017
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
application number: M017
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642205menthol 13.5 % / methyl salicylate 29.95 % Topical OintmentPSNda28097f-4b5c-6159-e053-2a95a90a7d964
2642205menthol 0.135 MG/MG / methyl salicylate 0.3 MG/MG Topical OintmentSCDda28097f-4b5c-6159-e053-2a95a90a7d964
2642205menthol 13.5 % / methyl salicylate 29.95 % Topical OintmentSYda28097f-4b5c-6159-e053-2a95a90a7d964
2642205menthol 13.5 % / methyl salicylate 30 % Topical OintmentSYda28097f-4b5c-6159-e053-2a95a90a7d964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-003-20609540003201 BOTTLE, GLASS in 1 BOX (60954-003-20) / 20 g in 1 BOTTLE, GLASS2023-07-03NoNoCurrent
60954-003-40609540003401 BOTTLE, GLASS in 1 BOX (60954-003-40) / 40 g in 1 BOTTLE, GLASS2023-07-03NoNoCurrent