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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONE VAGINAL INSERTSPROGESTERONEGlenmark Pharmaceuticals Inc., USA41682665-e889-4e2a-9382-88f6bcc302372026-04-17Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
DHEA ForteDEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,BioActive Nutritionals, Inc.663affc1-0998-4231-b284-ff3e2a7807b92026-04-03WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEBioActive Nutritional, Inc.cddb5afa-9825-418d-acf6-cffbb0fc39c32026-03-10WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEAmneal Pharmaceuticals LLC4de0715d-a3b9-42fa-b4e4-6371151fd75c2026-02-24Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONENorthstar Rx LLC73229a76-8de3-4cea-886f-568f0b817fea2026-02-19Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEXiromed, LLC0bf317a8-96d6-849d-7850-9084205a53152026-02-17Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEProficient Rx LP199c8575-e113-468f-8eb7-c4930030649c2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEBryant Ranch Prepack46d97ca6-970f-478f-81ff-1b9a9f6cb2f72026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.eca6a7c0-7f58-4dcf-aec0-9d44fd594aa12026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONENuCare Pharmaceuticals,Inc.4884017f-3314-cd26-e063-6294a90a4e7e2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONENuCare Pharmaceuticals, Inc.4874ee1b-f661-05f7-e063-6394a90a2b8b2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Progesterone 1538PROGESTERONEProfessional Complementary Health Formulasa5b8449e-ae6f-48c1-8b71-2dd3c5332cc12026-01-08WarningsExact identifier
unii: 4G7DS2Q64Y
PMS Drops 2124PMS DROPSProfessional Complementary Health Formulasd05bfbbe-d19d-4fd5-8679-bf17d0b618402026-01-08WarningsExact identifier
unii: 4G7DS2Q64Y
Fem Pro Drops 2025FEM PRO DROPSProfessional Complementary Health Formulase90ddaec-fc0e-4277-9cc6-6d3973d8e1ee2026-01-08WarningsExact identifier
unii: 4G7DS2Q64Y
Solvent/Small Ring Combination 9317SOLVENT/SMALL RING COMBINATIONProfessional Complementary Health Formulas01a1b313-3edb-4907-9d9b-bb1d1061b4ef2026-01-08WarningsExact identifier
unii: 1S4CJB5ZGN
ProgesteronePROGESTERONENorthwind Health Company, LLCfcebe343-18ac-d4cd-e053-6294a90a72d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
EstroPRO Homeopathic OrganotherapyAGNUS CASTUS, ANGELICA SIN, APIS MEL, CIMICIFUGA RAC, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM, GLYCYRRHIZA, OOPHORINUM, PROGESTERONE, SEPIAProBlen4696d365-7667-c25e-e063-6294a90a8dea2025-12-22WarningsExact identifier
unii: 4G7DS2Q64Y
AndrobalanceDHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.e231695a-165a-419e-b594-34f9522503ac2025-12-18WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEDirect_Rx462ae686-7264-4852-e063-6294a90aae982025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y

Reported adverse events (FAERS/openFDA)#

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