FDA.reportPublic FDA data

CAPZIX CREAM

Manufacturer
Toprail Chp Llc. | Southeast Holding Corp
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:43:38

Label at a glance#

ProductCAPZIX
Active ingredientCAPSAICIN
Label structure9 sections

Storage and handling

Other Information: STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:Capsaicin 0.1%

OTC - PURPOSE SECTION

Purpose:Topical Analgesic

INDICATIONS & USAGE SECTION

Uses:Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

Warnings:For external use only. Avoid contact with eyes.
Do notapply to wounds or damaged skin. Do notbandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask  doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions– Adults and children over 18
Apply to affected area not more than 3 to 4 times daily.
If product comes in contact with hands, wash with soap and water.
For children under 18 years of age ask a doctor.

STORAGE AND HANDLING SECTION

Other Information:STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.

SPL UNCLASSIFIED SECTION

High Potency Pain Relief

For Arthritis, Sore Muscles, Joint and Back Pain Relief

NDC# 72847-316-20

Distributed by: TopRail Medical Products   Glencoe, IL   www.toprailmedical.com   Made in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

die cutdie cut

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN5
646333capsaicin 1 MG/ML Topical CreamSCD5
646333capsaicin 0.1 % Topical CreamSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372847316201GTIN-13: 0372847316201
EAN-13: 0372847316201
GTIN-12: 372847316201
UPC-A: 372847316201
GTIN storage (14 digits): 00372847316201		Label-1.jpg

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
72847-316-20CAPZIX1 in 1 CARTONCREAM15
72847-316-20CAPZIX56.6 g in 1 TUBECREAM56.65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72847-316-20GM - Gram72847-316444cf649-43c7-4643-a83f-d9f77142ae2312024-02-14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72847-31672847-316-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
SORBITOL506T60A25RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-31full-release2026-06-01 00:32:52

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
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact identifier
ndc (package): 72847-316-20
ndc (product): 72847-316
ndc11 (package): 72847031620
spl id: 436cdb27-a019-bc3d-e063-6394a90a45db
spl set id: a4555840-cf8f-45d8-90bb-3581102b58a7

Reported adverse events (FAERS/openFDA)#

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