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 | Type |
|---|---|---|---|
| PENTACEL - Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd. | Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd. | 2026-04-28 | VACCINE LABEL |
| PENTACEL - A-S Medication Solutions | A-S Medication Solutions | 2025-05-16 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-561-01 | PENTACEL | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 2.5 mL | 26 [D'ag'U] in 0.5mL | 13 |
| 49281-561-01 | PENTACEL | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 2.5 mL | 7 [D'ag'U] in 0.5mL | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49281-561 | PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.] | 9 | Unmatched | 20250403_67d5c665-ca88-49ba-b7d3-7145d9878cf0.zip |
| 49281-561 | PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [A-S MEDICATION SOLUTIONS] | 1 | Unmatched | 20250523_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | 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 | 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 | 19371312D4 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9a61f1ae-d3a4-68d7-e053-2a95a90a4333 | 2020-12-03 | Warnings | C151H8M554 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9aefc830-329c-5e35-e053-2a95a90a6ffe | 2020-11-30 | Warnings | C151H8M554 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9af2d6f4-baa8-5da9-e053-2995a90a3dac | 2020-11-30 | Warnings | C151H8M554 |
| 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 | 19371312D4 |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | 1HG84L3525 |
| Water-Jel 3-in-1 Antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE | Water-Jel Technologies | d5fcaffd-af38-4285-a79c-6df7424c76fa | 2017-11-16 | Warnings | 19371312D4 |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| CVS Triple Antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B | CVS Pharmacy | 454bfeed-f58f-003a-e054-00144ff8d46c | 2017-01-04 | Warnings | 19371312D4 |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.