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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017
Capsaicin 0.025% CreamCAPSAICIN 0.025%Puretek Corporation28f00df0-c416-f17b-e063-6294a90a55702025-01-02WarningsExact identifier
application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint CreamCAMPHOR, MENTHOL, METHYL SALICYLATETai Guk Pharm. Co., Ltd.8f29ffd7-48b9-109f-e053-2995a90ab2152025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Arthritis Pain Relief Cream CapsaisinCAPSAISINTai Guk Pharm. Co., Ltd.8f286a9d-8765-21b3-e053-2a95a90ae43a2025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.8f2aa11d-d794-6f3e-e053-2995a90a1d9d2025-01-01WarningsExact identifier
application number: M017
HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.b9d033f3-4d12-a2c8-e053-2995a90ac7f12025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact 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