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 22 of 31 · 617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact identifier
unii: 19371312D4
Members Mark Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSam's West Inc200f4020-7699-4a9e-8fab-2d3df9e768362024-09-05WarningsExact identifier
unii: 19371312D4
Leader Poly BacitracinBACITRACIN ZINC POLYMIXIN B SULFATECardinal Health 110 dba LEADER20d7624f-cafa-25e1-e063-6394a90a44392024-08-29WarningsExact identifier
unii: 19371312D4
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BMeijer Distribution Incedcb423e-b5c2-4e26-8f7f-9b9ee575042c2024-08-19WarningsExact identifier
unii: 19371312D4
polycinBACITRACIN ZINC AND POLYMYXIN B SULFATESNuCare Pharmaceuticals,Inc.5d55e918-98a0-4989-e053-2a91aa0a9ad72024-08-14Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWildeman Business Group1f96450a-3bda-1f0a-e063-6294a90a514f2024-08-13WarningsExact identifier
unii: 19371312D4
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEProvision Medicalbbf4b99c-9738-4855-82a6-f4e213924ec92024-08-09WarningsExact identifier
unii: 19371312D4
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATESomerset Therapeutics, LLC93d52a75-9a96-4f96-be41-9ccdcabc09332024-08-06Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.60f5cfcf-cdb2-0e45-e053-2991aa0ae85a2024-07-18Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.54da7bef-c3b0-4353-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
unii: 19371312D4
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICRising Pharma Holdings, Inc.35768adc-b578-4c2e-b461-22de3135a7892024-06-10Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEA-S Medication Solutions6791e6c3-514d-4b98-8887-ca2b894576b52024-06-10Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONENuCare Pharmaceuticals,Inc.5f9c25b1-67d0-11ae-e053-2a91aa0ad8f42024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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