FDA.reportPublic FDA data

NDC 49281-561 - 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
49281-561
Package NDCs from labels
49281-561-01
Manufacturer
Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.
Effective date
2026-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PENTACEL - Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.2026-04-28VACCINE LABEL
PENTACEL - A-S Medication SolutionsA-S Medication Solutions2025-05-16VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-561-01PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION2.5 mL26 [D'ag'U] in 0.5mL13
49281-561-01PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION2.5 mL7 [D'ag'U] in 0.5mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-561PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]9Unmatched20250403_67d5c665-ca88-49ba-b7d3-7145d9878cf0.zip
49281-561PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [A-S MEDICATION SOLUTIONS]1Unmatched20250523_e7a819d7-a597-4c91-9078-7cd20ac34410.zip

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 10 of 31 · 617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POLVO DE SULFA FIRST AID ANTIBIOTICBACITRACIN ZINC, POLYMYXIN B SULFATEGRANDALL DISTRIBUTING, LLC1d8e3a03-a39f-a99e-e063-6394a90a31db2025-10-28WarningsExact identifier
unii: 19371312D4
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MaxitrolNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEHarrow Eye, LLCecfb954f-5554-0ad2-e053-2995a90a75162025-10-24Warnings, Adverse reactionsExact identifier
unii: 19371312D4
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA54c1d306-dc3b-2885-e054-00144ff8d46c2025-10-22WarningsExact identifier
unii: 19371312D4
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC4124e9e2-397f-8921-e063-6394a90a5ffe2025-10-14WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEBausch & Lomb Incoporated986e5b75-39fc-480f-9026-191b2d15dea12025-10-13Warnings, Adverse reactionsExact identifier
unii: 19371312D4
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEMedline Industries, LP301ebb9a-033b-4f04-99ff-571e921924ca2025-10-09WarningsExact identifier
unii: 19371312D4
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEAmneal Pharmaceuticals NY LLCbea0457d-40a7-4af9-ac77-b042356801762025-10-06Warnings, Adverse reactionsExact identifier
unii: 19371312D4
TheraCare Triple Antibiotic Pain ReliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINEVeridian Healthcarefaf73908-324f-27f5-e053-6394a90aa06e2025-10-02WarningsExact identifier
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATESagent Pharmaceuticals7dc505aa-64b0-4b7f-8ee3-2945bde40a342025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPreferred Pharmaceuticals Inc.ac5b585c-050d-44a2-80d2-642597dc88922025-10-01WarningsExact identifier
unii: 19371312D4
Double AntibioticBACITRACIN ZINC POLYMYXIN B SULFATEEncube Ethicals, Inc.8f00b059-6729-4fae-8e8c-e14fe8838c592025-09-30WarningsExact identifier
unii: 19371312D4
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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