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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Femarone 20FEMARONE 20Wise Essentials LLC44ea74ce-2ba1-e578-e063-6394a90ab72d2025-12-13WarningsExact identifier
unii: 4G7DS2Q64Y
BUNUSS Phyto-Pro Skin CreamPROGESTERONEJiashen International Trade Limited44e1ec89-e2ea-d438-e063-6294a90a41f42025-12-01WarningsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0b3da881-4720-cdee-e063-6394a90aee992025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.41c9546c-a854-4395-9506-d1be61f4e60f2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.c768aead-153b-42f3-bb4d-b06e30ebad802025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
P25 Progesterone CreamPROGESTERONESHYNE BRANDSc47169b7-1b6a-2ad0-e053-2995a90a0b192025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
P75 Lav Progesterone CreamPROGESTERONESHYNE BRANDSc4711337-7c1f-3556-e053-2a95a90a7b822025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
P75 Maxx with Retinol All Natural Progesterone 75 CreamP75 PROGESTERONE CREAMSHYNE BRANDSc470a8a5-15b4-1c9c-e053-2995a90afbcb2025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
P50 Progesterone CreamPROGESTERONESHYNE BRANDSc47121df-6c04-b273-e053-2a95a90aa5492025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
Progest-Oil-1oz-SBPROGEST-OIL-1OZ-SBShyne Brands/BIOLabs PRO37cf297c-6bf3-bd82-e063-6294a90a32722025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
Progest-Oil-2oz-SBPROGEST-OIL-2OZ-SBShyne Brands/BIOLabs PRO37d12a8e-20d5-60d3-e063-6294a90a81442025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
Balance Plus CreamESTRIOL,ESTRADIOL,PROGESTERONE,DHEASHYNE BRANDS/BIOLabs PRO37e5e4ae-8cb1-19bb-e063-6294a90ac43d2025-06-01WarningsExact identifier
unii: 4G7DS2Q64Y
Female StimulantLILIUM TIGRINUM, BOVISTA, CYPRIPEDIUM PUBESCENS, HYDRASTIS CANADENSIS, PETROSELINUM SATIVUM, AQUILEGIA VULGARIS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), KREOSOTUM, OOPHORINUM (SUIS), UTERUS (SUIS), FOLLICULINUM, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, SEPIA, PINEAL GLAND (SUIS), HYPOPHYSIS SUIS, ACONITICUM ACIDUM CIS-, APIS VENENUM PURUM, ESTRADIOL, PROGESTERONE, TESTOSTERONE, PLACENTA TOTALIS SUIS, FAECALIS (ALKALIGENES), MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.18d072ec-93e1-4e20-82db-98e80b81c3632025-05-27WarningsExact identifier
unii: 4G7DS2Q64Y
Hormone BalanceACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDr. Donna Restivo DC421707d6-31c1-4d57-b017-796fc872efe42025-05-23WarningsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONEBioActive Nutritional, Inc.0de91238-dacc-4a5c-86d8-ad94024b2c952025-05-20WarningsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEBryant Ranch Prepack0aeb0f0f-2749-416b-942f-83950200fd752025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEAsclemed USA, Inc.342a096d-df6f-47de-bdd1-ec259638e4762025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
Prostate LiquescenceSABAL SERRULATA, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ESTRADIOL, PROGESTERONE, CONIUM MACULATUM ASTERIAS RUBENS, EUPHORBIUM OFFICINARUM, TRITICUM REPENS, CALCAREA FLUORICA, ARSENICUM ALBUMNutritional Specialties, Inc.0cb4729c-63cd-463b-b1c4-df85118986d02025-04-07WarningsExact identifier
unii: 4G7DS2Q64Y
PROGESTERONEPROGESTERONEXIROMED, LLCdcfa4050-d142-b774-369f-8a421eb23c622025-03-06Warnings, Adverse reactionsExact identifier
unii: 4G7DS2Q64Y
ProgesteronePROGESTERONENewton Laboratories, Inc.9e038e0b-a124-1870-e053-2995a90a49f82025-02-10WarningsExact identifier
unii: 4G7DS2Q64Y

Reported adverse events (FAERS/openFDA)#

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