FDA.reportPublic FDA data

Capsaicin

Manufacturer
PHARMACURE LLC
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:30

Label at a glance#

ProductCapsaicin
Active ingredientCAPSAICIN
Label structure7 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 of age 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 18 years : ask a doctor

Label contents#

Full prescribing information#

Active Ingredient                                     Purpose

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.035%                                      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.

Do not use

• On wounds or damaged skin.

• If you are allergic to capsicum or chili peppers.

When using this product

• 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

• Conditions worsens or does not improve after regular use.
• Severe burning persists o blistering occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and children 18 years of age 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 18 years: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 15°-30°C (59°-86°F).
  • Protect product from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-011-01Capsaicin1 in 1 BOXCREAM11
79643-011-01Capsaicin100 g in 1 TUBECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-011CAPSAICIN CREAM [PHARMACURE LLC]1Current NDC, 2 package rows20250207_b2b2de93-d957-43d7-a2a8-b46bcaea1f0d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-011-01GM - Gram79643-0113992615a-5205-405e-a7c4-d165dfd733c312025-03-04

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79643-01179643-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HEMPTD1MUT01Q7IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
RESVERATROLQ369O8926LIACT
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATEZ6GFR7R72YIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
CAPSAICINS07O44R1ZMACTIB

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
CapsaicinCAPSAICINPHARMACURE LLCb2b2de93-d957-43d7-a2a8-b46bcaea1f0d2025-02-04WarningsExact identifier
ndc (package): 79643-011-01
ndc (product): 79643-011
ndc11 (package): 79643001101
spl id: 2d52cb80-e148-a0bf-e063-6294a90a7f8f
spl set id: b2b2de93-d957-43d7-a2a8-b46bcaea1f0d

Reported adverse events (FAERS/openFDA)#

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