FDA.reportPublic FDA data

NDC 58198-0507 - Component E-C With Tylan

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
58198-0507
Package NDCs from labels
58198-0507-2
Manufacturer
Elanco US Inc.
Effective date
2025-11-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Component E-C With Tylan - Elanco US Inc.Elanco US Inc.2025-11-21PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0507-2Component E-C With Tylan1 in 1 POUCHIMPLANT111
58198-0507-2Component E-C With Tylan5 in 1 CARTONIMPLANT511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0507COMPONENT E-C WITH TYLAN (PROGESTERONE, ESTRADIOL BENZOATE, TYLOSIN TARTRATE) IMPLANT [ELANCO US INC.]102 package rows20250122_bfc05acf-01ff-4b77-ae5c-7d5da9c03aa9.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 4 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONEPROGESTERONEDirect Rxdc9e2088-e11e-7d32-e053-2a95a90a29952025-01-22WarningsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEdirect rxc33e6c10-3149-57c3-e053-2995a90a3fa12025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Strength FALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS)BioActive Nutritional, Inc.a4f3a8e7-0a28-4aa0-ba0c-201807d62c962025-01-03WarningsExact identifier
unii: 4G7DS2Q64Y
Progesterone PhenolicPROGESTERONEEnergique, Inc.177c7d38-d133-4e3b-a81e-f6bacd39b1472024-10-29WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEFresenius Kabi USA, LLCa479b395-1e1a-4d2a-8feb-68a15c47225f2024-10-15Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 4G7DS2Q64Y
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
unii: 4G7DS2Q64Y
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEBryant Ranch Prepack1220b231-4765-4879-acb8-d7887d863a282024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0d976866-81b3-5db8-e063-6294a90a39f92024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Inc.83cfc12e-75d1-4284-bcc3-beadcbd271712024-07-09Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEProficient Rx LP80a63b2b-96be-423d-abbd-13acc802f6da2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTRINES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, PROGESTERONE, OXYTOCINCarolinas Weight Loss Institute66249339-1e80-449f-9c2a-a030cdc71a0c2024-05-23WarningsExact identifier
unii: 4G7DS2Q64Y
CrinonePROGESTERONEAllergan, Inc.75e97aa1-daa4-45f9-b2e2-1a371302914e2024-05-21Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEBryant Ranch Prepack1c71a4b0-1347-498f-8124-f4cb4be27b612024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEBryant Ranch Prepackb74caa23-a5b8-42dd-ab48-4b7a2f015deb2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, OXYTOCIN, PROGESTERONECarolinas Weight Loss Institute52ce70ad-7ed6-4559-8c4c-590bf7b10e652024-05-13WarningsExact identifier
unii: 4G7DS2Q64Y
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEDeseret Biologicals, Inc.ef33af80-5f72-4635-a8ae-f48376efb4512024-03-14WarningsExact identifier
unii: 4G7DS2Q64Y
Hormone CombinationACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDeseret Biologicals, Inc.22908e3d-492c-4b18-a070-076f99a813142024-03-11WarningsExact identifier
unii: 4G7DS2Q64Y

Reported adverse events (FAERS/openFDA)#

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