FDA.reportPublic FDA data

NDC 49281-562-58 - QUADRACEL

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
49281-562
Requested NDC
49281-562-58
Package NDCs from labels
49281-562-58, 49281-562-10
Manufacturer
Sanofi Pasteur Inc. | Sanofi Pasteur Limited
Effective date
2023-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
QUADRACEL - Sanofi Pasteur Inc. | Sanofi Pasteur LimitedSanofi Pasteur Inc. | Sanofi Pasteur Limited2023-08-21VACCINE LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-562-10ML - Milliliter49281-5625c025688-447b-4033-9ffd-ccdd92626ef112015-05-05
49281-562-58ML - Milliliter49281-562fb3f7446-235b-42b7-9962-1a8983531a5d12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT8C367IY4EYQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGENACTIVE INGREDIENT1O0600285AQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS PERTACTIN ANTIGENACTIVE INGREDIENT63GD90PP8XQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)ACTIVE INGREDIENTF4TN0IPY37QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT0LVY784C09QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT23JE9KDF4RQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT459ROM8M9MQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY8C367IY4EYQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGENACTIVE MOIETY1O0600285AQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS PERTACTIN ANTIGENACTIVE MOIETY63GD90PP8XQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)ACTIVE MOIETYF4TN0IPY37QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY0LVY784C09QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY23JE9KDF4RQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY459ROM8M9MQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
ALBUMIN BOVINEINACTIVE INGREDIENT27432CM55QQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
GLUTARALINACTIVE INGREDIENTT3C89M417NQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
NEOMYCININACTIVE INGREDIENTI16QD7X297QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLYMYXIN B SULFATEINACTIVE INGREDIENT19371312D4QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RQUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]1

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 29 · 567 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEREMEDYREPACK INC.c68818b2-d849-41d2-be07-731244afbbac2026-09-09Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
unii: 19371312D4
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
unii: 19371312D4
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
unii: 19371312D4
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
unii: 19371312D4
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
unii: 19371312D4
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
unii: 19371312D4
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
unii: 19371312D4
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
unii: 19371312D4
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
unii: 19371312D4
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
unii: 19371312D4
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
unii: 19371312D4
First Aid Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC3459a453-0a94-4122-adad-bb120daecd9e2026-08-18WarningsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMPreferred Pharmacetucials Inc.65293418-c6ad-43d8-948c-e1949c0afc312026-08-17Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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