FDA.reportPublic FDA data

GoodSense Cooling Pain Relief Gel

Manufacturer
Geiss, Destin & Dunn, Inc
Effective date
2025-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:02

Label at a glance#

ProductGoodSense Cooling Pain Relief
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic.

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

WARNINGS SECTION

For external use only.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.

Stop use and ask a doctor if the condition worsens, rash or irritation develops and lasts for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, and yellow 5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-297-03GoodSense Cooling Pain Relief1 in 1 CARTONGEL12
50804-297-03GoodSense Cooling Pain Relief89 mL in 1 TUBEGEL892

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-297-03ML - Milliliter50804-297e89fcce6-b5b4-43e4-8db9-e8e0c645487612025-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-29750804-297-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AACTIB
CARBOMER 9404Q93RCW27EIACT
MAGNESIUM SULFATEDE08037SABIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
ndc (package): 50804-297-03
ndc (product): 50804-297
ndc11 (package): 50804029703
spl id: 3a5d55cc-6cda-ca90-e063-6294a90a6843
spl set id: 2e5e1375-df07-9a43-e063-6394a90a9938

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.