NDC 49281-560 - PENTACEL

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: 49281-560
Package NDCs from labels: 49281-560-05
Manufacturer: Sanofi Pasteur Inc. | Sanofi Pasteur Limited
Effective date: 2022-07-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PENTACEL - Sanofi Pasteur Inc. \| Sanofi Pasteur Limited	Sanofi Pasteur Inc. \| Sanofi Pasteur Limited	2022-07-29	VACCINE LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	8C367IY4EY	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN	ACTIVE INGREDIENT	1O0600285A	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN	ACTIVE INGREDIENT	63GD90PP8X	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	F4TN0IPY37	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	K3W1N8YP13	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	IRH51QN26H	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	ACTIVE INGREDIENT	FLV5I5W26R	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	0LVY784C09	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	23JE9KDF4R	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE INGREDIENT	459ROM8M9M	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	8C367IY4EY	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN	ACTIVE MOIETY	1O0600285A	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN	ACTIVE MOIETY	63GD90PP8X	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)	ACTIVE MOIETY	F4TN0IPY37	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	K3W1N8YP13	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	IRH51QN26H	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	ACTIVE MOIETY	FLV5I5W26R	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	0LVY784C09	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	23JE9KDF4R	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)	ACTIVE MOIETY	459ROM8M9M	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
ALBUMIN BOVINE	INACTIVE INGREDIENT	27432CM55Q	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
ALUMINUM PHOSPHATE	INACTIVE INGREDIENT	F92V3S521O	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
FORMALDEHYDE	INACTIVE INGREDIENT	1HG84L3525	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
GLUTARAL	INACTIVE INGREDIENT	T3C89M417N	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
NEOMYCIN	INACTIVE INGREDIENT	I16QD7X297	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLYMYXIN B SULFATE	INACTIVE INGREDIENT	19371312D4	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]	10

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 15 of 29 · 567 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NATUREPLEX ANTIBIOTIC	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Natureplex LLC	86ea3452-c810-4c9a-9f52-bcb0688020f9	2025-01-15	Warnings	Exact identifier unii: 19371312D4
Antibiotic Application	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	da436c35-a98f-4df7-9d23-885564734cef	2025-01-13	Warnings	Exact identifier unii: 19371312D4
STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	74ed2a6f-824c-a1ff-e053-2a91aa0a57c0	2025-01-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b83	2025-01-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	7610bf80-61b7-982f-e053-2a91aa0ac1bb	2025-01-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier unii: 19371312D4
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier unii: 19371312D4
T-27	WATER	DNA Labs, Inc.	f0e9afd7-64a4-4b85-9c5f-4bf07ba4b481	2025-01-09	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER FOR INJECTION	Medefil, Inc.	99e99a50-82d5-aff6-e053-2a95a90a8c56	2025-01-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
BACTERIOSTATIC WATER	BACTERIOSTATIC WATER	HF Acquisition Co LLC, DBA HealthFirst	99b0ef9b-600a-40dc-e053-2a95a90aa07e	2025-01-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	99b1cb12-0b2d-0c0f-e053-2a95a90ac3b6	2025-01-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC	Bausch & Lomb Incorporated	f3231f1c-665e-4efa-baa1-83bf296b2f8f	2025-01-02	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE	Bausch & Lomb Incorporated	3b00eb5c-dd98-467e-a883-04c37a8ecc42	2025-01-02	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
AVON HeXashield Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Tai Guk Pharm. Co., Ltd.	8e0cb861-d8aa-1f71-e053-2a95a90aaa88	2025-01-01	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	087694c2-4b1b-e293-e063-6294a90a961f	2024-12-31	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	TRIFECTA PHARMACEUTICALS USA LLC	0c017b10-29b6-e30f-e063-6294a90a8a3c	2024-12-31	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic and Pain Relief	BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	0bf08cf6-be3f-f9aa-e063-6294a90a4393	2024-12-31	Warnings	Exact identifier unii: 19371312D4
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	f1a05d5f-74f2-17a1-e053-2995a90ab0e7	2024-12-31	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	a7e55c43-4345-4710-e053-2995a90aeee7	2024-12-30	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Bacitracin Zinc and Polymyxin B Sulfate	BACITRACIN ZINC AND POLYMYXIN B SULFATE	NuCare Pharmaceuticals,Inc.	a73654f4-949d-3da4-e053-2995a90a1fc3	2024-12-30	Warnings, Adverse reactions	Exact identifier unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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