FDA.reportPublic FDA data

Stafac 500 - Phibro Animal Health

Manufacturer
Phibro Animal Health
Effective date
2026-08-19
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-08-27 00:01:32

Label at a glance#

ProductStafac 500
Active ingredientVIRGINIAMYCIN
Label structure7 sections

Dosage and administration

Mixing Directions—Swine Stafac 500 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 500 required from the table below. Dilute Stafac 500 with a portion of one of the feed ingredients (enough to make a quantity equal to 10 lb per ton) before final mixing. Swine Required level of virginiamycin activity per ton of Type C Medicated Fe...

Storage and handling

Feed Continuously as Sole Ration Store At Or Below 25 o C (77 o F), Excursions Permitted Up to 40 o C (104 o F) Close Container After Use NOT FOR HUMAN USE Restricted Drug (California) – Use Only as Directed   Question/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact Phibro Animal Health Corporation at 888-403-0074 or www.pahc.com. To report side effects, contact Phibro Animal Health...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Type A Medicated Article Mix with swine and poultry feed

Active Drug Ingredient

DESCRIPTION SECTION

Virginiamycin : 50%

(Contains 227g virginiamycin activity per lb)

Caution

PRECAUTIONS SECTION

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Inert Ingredients:

SPL UNCLASSIFIED SECTION

Calcium carbonate, carboxymethylcellulose, mineral oil

For Further Manufacture Only.

Follow Directions For Use.

Approved by FDA under NADA # 091-467

301-8001-10

Stafac is a registered trademark of Phibro Animal Health Corporation

Distributed by: Phibro Animal Health Corporation, Teaneck, NJ 07666

Made in Canada

Directions for Use

DOSAGE & ADMINISTRATION SECTION

Mixing Directions—Swine

Stafac 500 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 500 required from the table below. Dilute Stafac 500 with a portion of one of the feed ingredients (enough to make a quantity equal to 10 lb per ton) before final mixing.

Swine

Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)

Required amount of Stafac 500 per ton of Type C Medicated Feed (complete feed)

Amount of virginiamycin activity provided to animal per lb of body weight per day

Treatment of swine dysentery in nonbreeding swine weighing over 120 lb

100 g for 2 weeks

200 g

2.27 mg

Treatment and control of swine dysentery in swine weighing up to 120 lb

100 g for 2 weeks

followed by 50 g

200 g

100 g

2.27 mg

1.14 mg

Aid in control of swine dysentery in swine weighing up to 120 lb

For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred

25 g

50 g

0.57 mg

►Caution: Not for use in breeding swine over 120 pounds.◄

Mixing Directions—Poultry

Mix 100 g Stafac 500 with enough of one of the feed ingredients to make 10 lb of an intermediate mix. Add 1 lb of the intermediate mix for each 5 g of virginiamycin needed to medicate a ton of feed.

Poultry

Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)

Required amount of Stafac 500 per ton of Type C Medicated Feed (complete feed)

For use in broiler chickens

Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin

20 g

40 g

Not for Use in Laying Chickens

Storage and Handling

STORAGE AND HANDLING SECTION

Feed Continuously as Sole Ration

Store At Or Below 25oC (77oF), Excursions Permitted Up to 40oC (104oF)

Close Container After Use

NOT FOR HUMAN USE

Restricted Drug (California) – Use Only as Directed

 

Question/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact Phibro Animal Health Corporation at 888-403-0074 or www.pahc.com. To report side effects, contact Phibro Animal Health Corporation at 1-888-475-7355. For additional information about reporting side effects, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

Stafac 500

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stafac 500Stafac 500 labelStafac 500 label

Stafac 500 Label - Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stafac 500 Label
Stafac 500 Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
VIRGINIAMYCINACTIVE INGREDIENTC49WS9N75L4
VIRGINIAMYCINACTIVE MOIETYC49WS9N75L4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3114
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP4
SOYBEAN OILINACTIVE INGREDIENT241ATL177A4

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66104-150166104-1501-9, 66104-1501-1, 66104-1501-2, 66104-1501-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
VIRGINIAMYCINC49WS9N75LACTIB
CALCIUM CARBONATEH0G9379FGKIACT
MINERAL OILT5L8T28FGPIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SOYBEAN OIL241ATL177AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102026-08-19daily-update2026-08-25 01:01:36
82023-11-06full-release2026-06-01 02:42:25

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 96 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED / ORAL50 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ASOLUTION / TOPICAL5.82 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRALESIONAL15 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, EXTENDED RELEASE / ORAL933 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, DELAYED RELEASE / ORAL4.2 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM, SOLUBLE / BUCCAL47 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYRUP / ORAL26.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRA-ARTICULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / INTRAMUSCULAR0.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE / DENTAL249 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE, FOR SUSPENSION / ORAL15.63 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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