FDA.reportPublic FDA data

NDC 49281-752-98 - TUBERSOL

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
49281-752
Requested NDC
49281-752-98
Package NDCs from labels
49281-752-78, 49281-752-21, 49281-752-98, 49281-752-22
Manufacturer
Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.
Effective date
2026-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.2026-05-01HUMAN PRESCRIPTION DRUG LABEL
TUBERSOL - A-S Medication SolutionsA-S Medication Solutions2023-08-14HUMAN PRESCRIPTION DRUG LABEL
TUBERSOL - A-S Medication SolutionsA-S Medication Solutions2023-06-15HUMAN PRESCRIPTION DRUG LABEL
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®Physicians Total Care, Inc.2013-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-752-21TUBERSOL1 in 1 CARTONINJECTION, SOLUTION118
49281-752-22TUBERSOL1 in 1 CARTONINJECTION, SOLUTION118
49281-752-78TUBERSOL1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION118
49281-752-98TUBERSOL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-752TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]16Current NDC, Legacy NDC, 4 package rows20240130_a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-752-21ML - Milliliter49281-752fcaf285b-9d80-496f-a1d3-07b4fc0d58c312013-04-01
49281-752-22ML - Milliliter49281-752db60372c-d5d6-47b4-91ec-debb2290cd1f12013-04-01
49281-752-78ML - Milliliter49281-752fcfefcdd-1456-466a-87bb-4b87b0c5d31d12014-05-02
49281-752-98ML - Milliliter49281-7522c4c089e-0905-46d1-8067-b1a13ace390112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tuberculin Purified Protein DerivativeACTIVE INGREDIENTI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Tuberculin Purified Protein DerivativeACTIVE MOIETYI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
PhenolINACTIVE INGREDIENT339NCG44TVTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Tuberculin Purified Protein DerivativeACTIVE INGREDIENTI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Tuberculin Purified Protein DerivativeACTIVE MOIETYI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PhenolINACTIVE INGREDIENT339NCG44TVTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

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 6 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
unii: 339NCG44TV
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
unii: 339NCG44TV
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
unii: 339NCG44TV
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
unii: 339NCG44TV
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
unii: 339NCG44TV
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, SANGUINARIA CANADENSIS, BLATTA ORIENTALIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGERDeseret Biologicals, Inc.795c34c6-71c8-4c36-b441-4bca55a435752023-12-04WarningsExact identifier
unii: 339NCG44TV
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron8774d7cc-5352-8e05-e053-2995a90a8fd62023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron8774b4fd-3a92-b3eb-e053-2995a90aa9942023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron8774f139-1e9e-d476-e053-2a95a90a454c2023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron87745d9f-0d5a-6cbf-e053-2a95a90a246a2023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron8774b7a5-543a-2e94-e053-2a95a90ae1f32023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoiron87745d9f-0d66-6cbf-e053-2a95a90a246a2023-11-15Exact identifier
unii: I7L8FKN87J
TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVEBoirondeb72580-bf6b-11e7-8268-424c583030312023-11-15Exact identifier
unii: I7L8FKN87J
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
unii: 339NCG44TV
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.c90278bf-b08a-4c79-86c0-dafd3b7756c62023-10-12WarningsExact identifier
unii: 339NCG44TV
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
unii: 339NCG44TV
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutionsca1199eb-2f86-4e27-967b-fb1c814dafd22023-08-14Warnings, Adverse reactionsExact identifier
application number: BLA103941
ndc (package): 50090-1668-0
ndc (product): 50090-1668
rxcui: 798415
rxcui: 313532
spl id: 5471ed3d-e3c2-407e-b467-cc5a1c8be2fa
spl set id: ca1199eb-2f86-4e27-967b-fb1c814dafd2
unii: I7L8FKN87J
Tap Water DetoxACETONE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARSENICUM METALLICUM, BARYTA MURIATICA, CADMIUM METALLICUM, CARBOLICUM ACIDUM, CHLORINUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, FERRUM METALLICUM, GERMANIUM METALLICUM, NATRUM FLUORATUM, PLUMBUM METALLICUM, RADIUM BROMATUM, VANADIUM METALLICUM, GLYPHOSATE HERBICIDENutritional Specialties, Inc.37a48fea-a8df-4d27-b0c7-e5704c25e72f2023-07-11WarningsExact identifier
unii: 339NCG44TV
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutions261efc52-a105-4c2c-a8ce-9eee20b62efc2023-06-15Warnings, Adverse reactionsExact identifier
application number: BLA103941
ndc (package): 50090-0261-0
ndc (product): 50090-0261
rxcui: 798415
rxcui: 313532
spl id: d88c50ba-fe16-4d39-8c61-42549f200d67
spl set id: 261efc52-a105-4c2c-a8ce-9eee20b62efc
unii: I7L8FKN87J
APLISOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutions9f025046-850f-46c1-bdfd-2450321443072023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 313532
unii: I7L8FKN87J

Reported adverse events (FAERS/openFDA)#

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