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FDA Approval

Allergies

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
King Bio Inc.
DUNS: 617901350
Effective Date
May 2, 2025
Labeling Type
OTC ANIMAL DRUG LABEL
euphrasia stricta(12 [hp_X] in 118 mL)
galphimia glauca flowering top(12 [hp_X] in 118 mL)
Histamine(12 [hp_X] in 118 mL)
Potassium chloride(12 [hp_X] in 118 mL)
Sodium chloride(12 [hp_X] in 118 mL)
Sulfur(12 [hp_X] in 118 mL)
Corticotropin(30 [hp_X] in 118 mL)
Onion(12 [hp_X] in 118 mL)
Arsenic trioxide(12 [hp_X] in 118 mL)
arisaema triphyllum root(12 [hp_X] in 118 mL)
arundo pliniana root(12 [hp_X] in 118 mL)
Cortisone acetate(12 [hp_X] in 118 mL)
schoenocaulon officinale seed(12 [hp_X] in 118 mL)
wyethia helenioides root(12 [hp_X] in 118 mL)
Saccharomyces cerevisiae(12 [hp_X] in 118 mL)
Naphthalene Trisulfonate(12 [hp_X] in 118 mL)
Cyclic adenosine phosphate(12 [hp_X] in 118 mL)
Ambrosia artemisiifolia pollen(12 [hp_X] in 118 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

King Bio Inc.

617901350

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Allergies

Product Details

NDC Product Code
57955-4809
Route of Administration
ORAL
Effective Date
May 2, 2025
euphrasia strictaActive
Code: C9642I91WLClass: ACTIBQuantity: 12 [hp_X] in 118 mL
galphimia glauca flowering topActive
Code: 93PH5Q8M7EClass: ACTIBQuantity: 12 [hp_X] in 118 mL
HistamineActive
Code: 3POA0Q644UClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIMQuantity: 12 [hp_X] in 118 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 12 [hp_X] in 118 mL
SulfurActive
Code: 70FD1KFU70Class: ACTIBQuantity: 12 [hp_X] in 118 mL
CorticotropinActive
Code: K0U68Q2TXAClass: ACTIBQuantity: 30 [hp_X] in 118 mL
OnionActive
Code: 492225Q21HClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Arsenic trioxideActive
Code: S7V92P67HOClass: ACTIBQuantity: 12 [hp_X] in 118 mL
arisaema triphyllum rootActive
Code: DM64K844DMClass: ACTIBQuantity: 12 [hp_X] in 118 mL
arundo pliniana rootActive
Code: ZXE7LB03WCClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Cortisone acetateActive
Code: 883WKN7W8XClass: ACTIBQuantity: 12 [hp_X] in 118 mL
schoenocaulon officinale seedActive
Code: 6NAF1689IOClass: ACTIBQuantity: 12 [hp_X] in 118 mL
wyethia helenioides rootActive
Code: J10PD1AQ0NClass: ACTIBQuantity: 12 [hp_X] in 118 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Saccharomyces cerevisiaeActive
Code: J17GBZ5VGXClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Naphthalene TrisulfonateActive
Code: 2166IN72UNClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Cyclic adenosine phosphateActive
Code: E0399OZS9NClass: ACTIBQuantity: 12 [hp_X] in 118 mL
Ambrosia artemisiifolia pollenActive
Code: 9W34L2CQ9AClass: ACTIBQuantity: 12 [hp_X] in 118 mL
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