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 16 of 29 · 567 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tripleantibioticapainscaritch	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	935106c6-8a9e-07fa-e053-2a95a90a2484	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	00c52a31-9bfa-a8bf-e063-6294a90ac4d7	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	Trifecta Pharmaceuticals Usa Llc	d04b397c-1608-4fd9-be28-ef7285d6a996	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Tripleantibioticointmentandpainrelief	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	91575333-5268-5d8f-e053-2a95a90a7a89	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Premier Value Max Strength Antibiotic plus pain relief	PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Pharmacy Value Alliance LLC	9767821e-054b-3bd3-e053-2a95a90a4b0e	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Premier Value Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab843664-a1e0-6716-e053-2995a90a2063	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab863d90-1a8f-3c1f-e053-2a95a90aa0a7	2024-12-20	Warnings	Exact identifier unii: 19371312D4
Family Wellness First Aid Antibiotic	FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA, LLC	9157681a-3ed1-096e-e053-2a95a90a05e3	2024-12-18	Warnings	Exact identifier unii: 19371312D4
Family Wellness Original	FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B	Trifecta Pharmaceuticals USA LLC.	915759af-0d4f-6a87-e053-2a95a90acbd6	2024-12-18	Warnings	Exact identifier unii: 19371312D4
Family Wellness Pain Scar Itch	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Trifecta Pharmaceutical USA LLC	9e507ec5-310d-3a21-e053-2a95a90a15a6	2024-12-18	Warnings	Exact identifier unii: 19371312D4
First Aid Antibiotic plus Burn Relief	BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI	Trifecta Pharmaceuticals USA LLC	048871e2-c917-292d-e063-6394a90af130	2024-12-18	Warnings	Exact identifier unii: 19371312D4
TheraCare Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	0c3fc798-9a97-5316-e063-6394a90a6830	2024-12-18	Warnings	Exact identifier unii: 19371312D4
Fendall Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	afda6fc3-7615-b0be-e053-2995a90a6208	2024-12-10	Warnings	Exact identifier unii: 059QF0KO0R
OP First Aid Series TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	cadebf07-dd48-4855-8296-7a91e28d7123	2024-12-05	Warnings	Exact identifier unii: 19371312D4
triple antibiotic and pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	f0864d78-23e6-4e6c-bc67-7ba3e6dd862c	2024-12-03	Warnings	Exact identifier unii: 19371312D4
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%	PURIFIED WATER 98.3%	Acme United Corporation	9248ee71-2d47-620d-e053-2995a90af5c8	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	6296e2ed-336b-b9af-e053-2991aa0aae0c	2024-11-26	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	cca454e0-b2bd-4215-bc06-426fcc3f7bd6	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	d3812fa3-9334-464d-b50c-98548ff76727	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
DANGTTEOL	MINERAL WATER	AQBC CO., LTD	27db14a9-3812-433f-e063-6394a90a11e7	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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