FDA.reportPublic FDA data

Capsaicin 0.035% cream

Manufacturer
Medcore LLC
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:45

Label at a glance#

ProductCapsaicin 0.035% cream
Active ingredientCAPSAICIN
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to simple backache arthritis strains sprains

Dosage and administration

Adults and children 18 years and older. Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily children under 18years：ask a doctor

Storage and handling

excursions permitted to 15-30C(59-86F). See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Capsaicin 0.035%

OTC - PURPOSE SECTION

Purpose

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only
Read all warnings and directions before use.
Test first on small area of skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed.get medical help or contact a Poison Control Center right away

Do not use :

OTC - DO NOT USE SECTION

On wounds or damaged skin
If you are allergic to capsicum or chili peppers

When using this product

OTC - WHEN USING SECTION

  • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • Do not tightly wrap or bandage the treated area
  • Do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or does not improve after regular use
  • Severe burning persists or blistering occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years and older.

  • Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application
  • for best results. Apply 3 to 4 times daily children under 18years：ask a doctor

Other Information

STORAGE AND HANDLING SECTION

excursions permitted to 15-30C(59-86F).
See USP Controlled Room Temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Poly(acrylic acid) solution, Polysorbate 80, Glycerin, polyethylene glycol-400, Sodium polyacrylate, SORBITOL, Carboxymethyl Cellulose Sodium, aluminium magnesium silicate, PHENOXYETHANOL, EDTA Disodium salt, Lemon oil, Water, Peppermint oil

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-417-10

Medcore LLC

Capsaicin 0.035% cream

100ml

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269
CapsaicinCapsaicin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577395capsaicin 0.035 % Topical CreamPSN1
577395capsaicin 0.35 MG/ML Topical CreamSCD1
577395capsaicin 0.035 % Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382461417109GTIN-13: 0382461417109
EAN-13: 0382461417109
GTIN-12: 382461417109
UPC-A: 382461417109
GTIN storage (14 digits): 00382461417109		capsaicin-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-417-10Capsaicin 0.035% cream100 mL in 1 BOTTLE, PUMPCREAM1001

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-41782461-417-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
GLYCERINPDC6A3C0OXIACT
POLYACRYLIC ACID (800000 MW)D0I6NSZ87UIACT
POLYSORBATE 806OZP39ZG8HIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
EDETATE DISODIUM7FLD91C86KIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
PEPPERMINT OILAV092KU4JHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT

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
Capsaicin 0.035% creamCAPSAICINMedcore LLC0236e1e4-c26c-4fff-a83b-143ce26d93bf2026-05-07WarningsExact identifier
ndc (package): 82461-417-10
ndc (product): 82461-417
ndc11 (package): 82461041710
spl id: 0371fc78-d964-4a3c-a2c3-7a1f6e8ad18a
spl set id: 0236e1e4-c26c-4fff-a83b-143ce26d93bf

Reported adverse events (FAERS/openFDA)#

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