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 28 of 29 · 567 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE	Proficient Rx LP	d1f55327-156f-44cd-b0fc-b1a938e8aa73	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Cuadriderma	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	ProMex LLC	4fa99b96-ab4b-4523-82bc-343dbaf39fb6	2022-01-25	Warnings	Exact identifier unii: 19371312D4
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc.	99d9030f-9118-412c-a377-d1df1c8fa723	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	704a41f5-b109-4c16-8d3e-1495c9917952	2021-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	fbc12c18-567b-41bc-89d0-efd29616615c	2021-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE	Proficient Rx LP	bd9f3220-6d42-4863-aa2a-b17b138d095d	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Trimethoprim sulfate and Polymyxin B sulfate	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	Proficient Rx LP	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Proficient Rx LP	d55f1783-9c49-4f90-9ff8-6f132e7b325e	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Asclemed USA, Inc.	7c78ec84-8b7c-42f1-a879-3bf27a1daa71	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 19371312D4
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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