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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgesteronePROGESTERONEDr. Reddys Laboratories, Inc.efded380-02ff-68c9-13e4-47a561ede4402024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAurobindo Pharma Limited7d73f08d-2de7-44b6-9e44-2d488fe025172024-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Hormone HarmonyACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEPro Weight Loss Inc.123f5269-45eb-4dcd-be66-76c6665b8d132024-01-22WarningsExact identifier
unii: 4G7DS2Q64Y
A09 FEMALE BALANCEARGENTUM NITRICUM, ATROPINUM SULPHURICUM, AURUM MURIATICUM NATRONATUM, BOS TAURUS OVARY, BOS TAURUS PANCREAS, BOS TAURUS PITUITARUM POSTERIUM, BOS TAURUS UTERUS, CIMICIFUGA RACEMOSA, ESTRONE, HELONIAS DIOICA, PROGESTERONE, PULSATILLA VULGARIS, SABINA, SEPIA, SEQUOIADENDRON GIGANTEUM WHOLE, SUS SCROFA PINEAL GLAND, SUS SCROFA SPLEEN, THIOSINAMINUM, THYROIDINUM, VIBURNUM OPULUSApex Energetics Inc.b8e1ba2a-f80f-158e-e053-2a95a90aacd12024-01-08WarningsExact identifier
unii: 4G7DS2Q64Y
R18 OVAGENADENOSINE TRIPHOSPHATE, AGNUS CASTUS, AMMONIUM CARBONICUM, AMMONIUM MURIATICUM, APIS MELLIFICA, LYCOPODIUM CLAVATUM, PLATINUM METALLICUM, PROGESTERONEApex Energetics Inc.bf4f268b-f6bc-2485-e053-2a95a90aced42024-01-08WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEA-S Medication Solutions96c59a1c-d562-46dd-868b-b2decdfef3192023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEEugia US LLC7d19df3b-94ed-4681-beae-9caaf137d0142023-09-12Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAsclemed USA, Inc.fd6b9861-04fc-42d8-90c8-021a69fe93e92023-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEA-S Medication Solutions5e0263c5-2cb6-4e02-b883-2c05492a62602023-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Progesterone ComboPROGESTERONENutritional Specialties, Inc.5ccf7bee-2da4-4347-8753-30680d7c1c032023-04-27WarningsExact identifier
unii: 4G7DS2Q64Y
Metabolic Correction BlendFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, PROGESTERONE, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, FERRUM METALLICUM, GRAPHITES, ADRENALINUM, PHOSPHORUSIHA Distribution, LLCe8ec4f7e-c9dd-46dd-a9ee-2b8b7bcea9a82023-03-21WarningsExact identifier
unii: 4G7DS2Q64Y
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAsclemed USA, Inc.19716042-8025-43a3-b26d-e0fd7d2587eb2022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAsclemed USA, Inc.efd6a8d8-c023-4d9f-b574-b14dc945203d2022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAsclemed USA, Inc.4a741977-1dbb-41e7-a560-9ac02936f8b12022-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEProficient Rx LPe1546b35-cfa8-4808-9652-db1ba675a4e32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEProficient Rx LP73e65b35-2266-48a3-98f8-521446a55c222022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
unii: 4G7DS2Q64Y
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
unii: 4G7DS2Q64Y

Reported adverse events (FAERS/openFDA)#

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