FDA.reportPublic FDA data

Capsaicin Cream

Manufacturer
Alexso, Inc
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:51

Label at a glance#

ProductCapsaicin
Active ingredientCAPSAICIN
Label structure11 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

Storage and handling

Store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CAPSAICIN – Capsaicin 0.025% Cream

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Capsaicin 0.025% Cream


Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

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

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

Capsaicin 0.025% cream

NDC 50488-1025-1

120 grams

Capsaicin 0.025% cream

NDC 50488-1025-5

50 grams

Capsaicin 0.025% cream

NDC 50488-1025-2

25 grams

Alexso, Inc

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-1025-1
Capsaicin 0.025% Cream
120 grams

PRINCIPAL DISPLAY PANEL NDC 50488-1025-1 Capsaicin 0.025% Cream 120 gramsPRINCIPAL DISPLAY PANEL NDC 50488-1025-1 Capsaicin 0.025% Cream 120 grams

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-1025-5
Capsaicin 0.025% Cream
50 grams

NDC 50488-1025-5 Capsaicin 0.025% Cream 50 gramsNDC 50488-1025-5 Capsaicin 0.025% Cream 50 grams

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-1025-2
Capsaicin 0.025% Cream
25 grams

NDC 50488-1025-2 Capsaicin 0.025% Cream 25 gramsNDC 50488-1025-2 Capsaicin 0.025% Cream 25 grams

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN6
198555capsaicin 0.25 MG/ML Topical CreamSCD6
198555capsaicin 0.025 % Topical CreamSY6

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
50488-1025-1Capsaicin1 in 1 CARTONCREAM16
50488-1025-1Capsaicin120 g in 1 TUBECREAM1206
50488-1025-2Capsaicin1 in 1 CARTONCREAM16
50488-1025-2Capsaicin25 g in 1 TUBECREAM256
50488-1025-5Capsaicin1 in 1 CARTONCREAM16
50488-1025-5Capsaicin50 g in 1 TUBECREAM506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1025CAPSAICIN CREAM [ALEXSO, INC]6Current NDC, Legacy NDC, 6 package rows20241208_433da27d-04fb-481a-bbb0-874bb72c806a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1025-1GM - Gram50488-1025d17846c1-27c2-4422-951e-81c30af4e47b12018-11-06
50488-1025-2GM - Gram50488-1025990eddfb-a7a5-4493-b6e9-371140c2fd9d12019-10-07
50488-1025-5GM - Gram50488-10259795f0e9-7933-4d81-9bc2-c7b3efa42c3812018-11-06

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
50488-102550488-1025-1, 50488-1025-5, 50488-1025-2

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
CAPSAICINS07O44R1ZMACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
LAURETH-7Z95S6G8201IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT

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
CapsaicinCAPSAICINAlexso, Inc433da27d-04fb-481a-bbb0-874bb72c806a2024-12-06WarningsExact identifier
ndc (package): 50488-1025-2
ndc (package): 50488-1025-5
ndc (package): 50488-1025-1
ndc (product): 50488-1025
ndc11 (package): 50488102505
ndc11 (package): 50488102502
ndc11 (package): 50488102501
spl id: 1eb282ca-46c9-4da5-b2e8-40819f4a6677
spl set id: 433da27d-04fb-481a-bbb0-874bb72c806a

Reported adverse events (FAERS/openFDA)#

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