Synovex

Manufacturer
Zoetis Inc.
Effective date
2026-06-12
Label type
OTC ANIMAL DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-06-16 05:10:02

Label at a glance#

ProductSynovex C
Active ingredientPROGESTERONE, ESTRADIOL BENZOATE
Label structure11 sections

Dosage and administration

Implant complete contents of one cartridge cell to each steer or heifer at implanting. Approved implantation technique is fully described in the package insert. NOTE : Never sacrifice careful, clean technique for speed of implantation.

Storage and handling

Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Synovex® C
(progesterone and estradiol benzoate implants)
100 mg progesterone and 10 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR BEEF CALVES

This product was manufactured by a non-sterilizing process.

TAKE TIME OBSERVE LABEL DIRECTIONS

Important: Read ALL sides of carton For subcutaneous ear implantation only.

Approved by FDA under NADA # 009-576

Restricted Drug (California) — Use Only as Directed

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

WARNINGS SECTION

No withdrawal period is required when used according to labeling. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves. Do not use in bull calves intended for reproduction. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal Law. Do not attempt salvage of implanted site for human or animal food.

USER SAFETY WARNINGS

SPL UNCLASSIFIED SECTION

Not for use in humans. Keep out of reach of children.

ANIMAL SAFETY WARNINGS

SPL UNCLASSIFIED SECTION

Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® C implants.

DIRECTIONS

SPL UNCLASSIFIED SECTION

Implant complete contents of one cartridge cell to each steer or heifer at implanting. Approved implantation technique is fully described in the package insert.

NOTE: Never sacrifice careful, clean technique for speed of implantation.

steps
steps

INDICATIONS FOR USE

SPL UNCLASSIFIED SECTION

• For increased rate of weight gain in beef calves 45 days of age and older and weighing up to 400 lbs.
• Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in beef calves 45 days of age and older and weighing up to 400 lbs. Safety and effectiveness following re-implantation have not been evaluated.

Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.
Do not use in bull calves intended for subsequent breeding, or in dairy cows.

Storage

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

QUESTIONS/COMMENTS?

SPL UNCLASSIFIED SECTION

For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

NET CONTENTS: 10 CARTRIDGES
Each Cartridge Contains 10 implants (100 implants total)

SPL UNCLASSIFIED SECTION

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Revised: June 2026

40056873

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40056873

label representation
label representation

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
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76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
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001f367b-fa14-49a0-865b-b395f2553601Product name220190611
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d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
estradiol benzoateACTIVE INGREDIENT1S4CJB5ZGN1
progesteroneACTIVE INGREDIENT4G7DS2Q64Y1
estradiolACTIVE MOIETY4TI98Z838E1
progesteroneACTIVE MOIETY4G7DS2Q64Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-390354771-3903-1, 54771-3903-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROGESTERONE4G7DS2Q64YACTIB
ESTRADIOL BENZOATE1S4CJB5ZGNACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62023-07-06full-release2026-06-01 02:42:06

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 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONEPROGESTERONEREMEDYREPACK INC.947ebb7c-492b-4b83-aa1c-81e282df64212026-08-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.404e0b45-339b-4304-8e33-5f4ffe8f8e252026-08-24Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ENDOMETRINPROGESTERONEFerring Pharmaceuticals Inc.2ba50fa9-b349-40cb-9a4b-1af8faa4ec092026-07-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEREMEDYREPACK INC.f7615864-be6e-47b4-bf35-145a361d7cc62026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PrometriumPROGESTERONEAcertis Pharmaceuticals, LLC1cf237ff-c4f8-4faa-a7aa-77599c8568892026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONERedpharm Drug5743b2e4-093f-c59a-e063-6394a90aae2b2026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthStar Rx LLCf392c6d9-1420-4735-aa01-f434da9b31b32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEA-S Medication Solutionsbc62ae6d-b609-432d-863f-a8ecd223d69a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEGolden State Medical Supply, Inc.312db3af-9dd2-d5e4-e063-6394a90af9992026-06-18Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE42c84fec-e5eb-78f7-e063-6294a90a4c0e2026-06-16Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1ba10f9d-6e91-4954-ac91-23adcf8805b02026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack74a7619a-8f74-4889-96f6-5bae478543e82026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEBionpharma Inc.41b3c3a7-5fb8-4451-a96c-2bd02613c0212026-05-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONESun Pharmaceutical Industries, Inc.fcdde0d0-4329-4725-a76b-684f9d97fe952026-05-19Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE1637ac18-3a37-f3d5-e063-6394a90af1572026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEA-S Medication Solutions566584fc-c76a-4e42-a62e-109a2903b9392026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Natural ProgesteronePROGESTERONEBioActive Nutritional, Inc.772629aa-af5e-4493-aaf2-3c75bfd7d8c22026-05-05WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Incd8bcc439-c21d-4eeb-9159-f51e0c60bd702026-04-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONE VAGINAL INSERTSPROGESTERONEGlenmark Pharmaceuticals Inc., USA41682665-e889-4e2a-9382-88f6bcc302372026-04-17Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBioActive Nutritional, Inc.cddb5afa-9825-418d-acf6-cffbb0fc39c32026-03-10WarningsName fallback
generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

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