NDC 49281-548 - 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: 49281-548
Package NDCs from labels: 49281-548-58
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 9 of 29 · 567 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dabur First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Dabur India Limited	229170a3-ef9e-597d-e063-6394a90acf8b	2025-11-18	Warnings	Exact identifier unii: 19371312D4
Sterile Water	WATER	Fresenius Kabi USA, LLC	fd823bef-c14c-4708-a18a-8aaa8470412f	2025-11-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Rapidol Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Pharmadel LLC	1ad22205-f8c3-b142-e063-6394a90a0044	2025-11-17	Warnings	Exact identifier unii: 19371312D4
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products USA, Inc.	3765c251-eb14-d60f-e063-6294a90a6a4d	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37f244fd-c02f-e66a-e063-6394a90aed81	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Amneal Pharmaceuticals NY LLC	6fff6c70-ea1f-449c-be0c-b989de36bd67	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
POLVO DE SULFA FIRST AID ANTIBIOTIC	BACITRACIN ZINC, POLYMYXIN B SULFATE	GRANDALL DISTRIBUTING, LLC	1d8e3a03-a39f-a99e-e063-6394a90a31db	2025-10-28	Warnings	Exact identifier unii: 19371312D4
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Maxitrol	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Harrow Eye, LLC	ecfb954f-5554-0ad2-e053-2995a90a7516	2025-10-24	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Tripleantibioticointmentandpainrelief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Trifecta Pharmaceuticals USA	54c1d306-dc3b-2885-e054-00144ff8d46c	2025-10-22	Warnings	Exact identifier unii: 19371312D4
Sterile Water	WATER	Becton Dickinson and Company	cab03cda-4660-4020-a3be-bf86242ff664	2025-10-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	4124e9e2-397f-8921-e063-6394a90a5ffe	2025-10-14	Warnings	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Bausch & Lomb Incoporated	986e5b75-39fc-480f-9026-191b2d15dea1	2025-10-13	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
MediChoice Triple Antibiotic	BACITRACIN	O&M HALYARD, INC.	8369f399-6f64-4441-be72-1f16c7306c0a	2025-10-09	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Medline Industries, LP	301ebb9a-033b-4f04-99ff-571e921924ca	2025-10-09	Warnings	Exact identifier unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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