FDA.reportPublic FDA data

NDC 0008-1279 - Torisel

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0008-1279
Package NDCs from labels
0008-1279-01
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth Lederle SRL
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ToriselWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth Lederle SRL2025-12-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-1279-01Torisel25 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE25 mL25 mg in 1mL39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-1279TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]38Unmatched20250323_95b7dc92-2180-42f1-8699-3c28f609e674.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMSIROLIMUSACTIVE INGREDIENT624KN6GM2TTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TEMSIROLIMUSACTIVE MOIETY624KN6GM2TTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
ALCOHOLINACTIVE INGREDIENT3K9958V90MTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26

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 65 of 153 · 3,054 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protecting FHSALCOHOLEcolab50d1e501-c143-4446-84e7-7f3f278166af2025-12-30WarningsExact identifier
unii: 3K9958V90M
Facilipro Protecting FHSALCOHOLEcolabd6fccda4-f565-406b-aeb6-585b59bddf512025-12-30WarningsExact identifier
unii: 3K9958V90M
Retail Hand SanitizerALCOHOLEcolab Inc.55e65545-9869-413b-8239-bd2d43fe36d82025-12-30WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
unii: 3K9958V90M
Refreshify Antiseptic Hand WipesALCOHOLEmes Commerce Group Inc.46d2f10e-e1c2-3ca2-e063-6394a90a602d2025-12-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PISTACHIO MATCHA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limiteddfd59d2e-9036-486a-b25b-7e5fe23421ce2025-12-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHANOLZep Inc.c72cf71f-e639-2854-e053-2a95a90ab30e2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Handstand Instant Hand SanitizerETHYL ALCOHOLZep Inc.9984beca-a66a-785c-e053-2995a90ae5ba2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Hand Sanitizer WipesETHANOLZep Inc.99867fc5-820e-6d6b-e053-2a95a90a07932025-12-26WarningsExact identifier
unii: 3K9958V90M
StellaLife Hand SanitizerALCOHOLStellaLife, Inc.a65b338d-5019-0cfc-e053-2a95a90ae8b22025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SUNDAE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedddda3587-1967-474a-8d9b-c6dad5448b2c2025-12-26WarningsExact identifier
unii: 3K9958V90M
ToriselTEMSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.95b7dc92-2180-42f1-8699-3c28f609e6742025-12-26Warnings, Adverse reactionsExact identifier
application number: NDA022088
ndc (package): 0008-1279-01
ndc (package): 0008-1179-01
ndc (package): 0008-1125-01
ndc (product): 0008-1179
rxcui: 725108
rxcui: 722289
spl id: 8731b3b1-29d9-46b1-a443-822d8057f773
spl set id: 95b7dc92-2180-42f1-8699-3c28f609e674
FRESH FEELS HAND SANITIZER MIST BERRY KISS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited39c8767d-46e8-4b26-be52-e5ed7d090d3e2025-12-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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