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 126 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense anti itchHYDROCORTISONEL. Perrigo Companyb7a896cc-1d78-45c0-a73e-aa1e117f7d3b2024-09-29WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLCb7362f21-f1a3-4edc-b5b6-a16680e05df32024-09-29WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B412ca2d1-064b-4438-aee1-fcb5cf27c7db2024-09-29WarningsExact identifier
application number: M017
Topcare AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC8c349cac-20e1-4600-9b0a-fcfe929551c52024-09-26WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEA-S Medication Solutions072dd455-24a5-4a44-aaef-d3e137d005a62024-09-26WarningsExact identifier
application number: M017
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact identifier
application number: M017
Caring Mill Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare22ca137a-576c-a13c-e063-6394a90ae7fc2024-09-23WarningsExact identifier
application number: M017
Signature Care Anti ItchHYDROCORTISONESafewayed0eb068-3ce6-423d-a7f8-c3456b7f60402024-09-23WarningsExact identifier
application number: M017
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.a07496e0-6fc2-4190-8a01-f513134ffb922024-09-23WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
application number: M017
Tibetree Cheezheng Joint Analgesic PatchCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd65a8a63f-1864-473e-be72-7840a6a5dee72024-09-20WarningsExact identifier
application number: M017
Cold Ice Analgesic GelMENTHOLDabur India Limited22915b2f-5f76-3e38-e063-6394a90a07b42024-09-20WarningsExact identifier
application number: M017
Exchange Select HydrocortisoneHYDROCORTISONEArmy & Air Force Exchange Service1b709db3-7dc1-4756-a8a0-dddda875dc572024-09-19WarningsExact 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