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 123 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact identifier
application number: M017
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENatural Essentials, Inc.fc23b2e2-4abc-4119-b8bd-305b4327f1dd2024-10-09WarningsExact identifier
application number: M017
KERACAREMENTHOL 1%Avlon Industries, Inc.f72eec6d-1204-4e03-8aed-d5bcf8d3bbce2024-10-09WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact 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