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FDA Approval

Regional Allergies Southern U.S.

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 20, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Epinephrine(12 [hp_X] in 59 mL)
Corticotropin(30 [hp_X] in 59 mL)
Onion(12 [hp_X] in 59 mL)
alnus serrulata bark(12 [hp_X] in 59 mL)
arisaema triphyllum root(12 [hp_X] in 59 mL)
arundo pliniana root(12 [hp_X] in 59 mL)
centaurea benedicta(12 [hp_X] in 59 mL)
Cortisone acetate(12 [hp_X] in 59 mL)
euphrasia stricta(12 [hp_X] in 59 mL)
galphimia glauca flowering top(12 [hp_X] in 59 mL)
Histamine(12 [hp_X] in 59 mL)
juglans cinerea branch bark/root bark(12 [hp_X] in 59 mL)
Potassium chloride(12 [hp_X] in 59 mL)
nasturtium officinale(12 [hp_X] in 59 mL)
Sodium chloride(12 [hp_X] in 59 mL)
toxicodendron pubescens leaf(12 [hp_X] in 59 mL)
schoenocaulon officinale seed(12 [hp_X] in 59 mL)
sassafras albidum root bark(12 [hp_X] in 59 mL)
Cyclic adenosine phosphate(12 [hp_X] in 59 mL)
Chicory leaf(12 [hp_X] in 59 mL)
Mucuna pruriens seed(12 [hp_X] in 59 mL)
Saccharomyces cerevisiae(12 [hp_X] in 59 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.

Regional Allergies Southern U.S.

Product Details

NDC Product Code
57955-0762
Route of Administration
ORAL
Effective Date
May 20, 2025
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 12 [hp_X] in 59 mL
CorticotropinActive
Code: K0U68Q2TXAClass: ACTIBQuantity: 30 [hp_X] in 59 mL
OnionActive
Code: 492225Q21HClass: ACTIBQuantity: 12 [hp_X] in 59 mL
alnus serrulata barkActive
Code: BQ5P19J9OLClass: ACTIBQuantity: 12 [hp_X] in 59 mL
arisaema triphyllum rootActive
Code: DM64K844DMClass: ACTIBQuantity: 12 [hp_X] in 59 mL
arundo pliniana rootActive
Code: ZXE7LB03WCClass: ACTIBQuantity: 12 [hp_X] in 59 mL
centaurea benedictaActive
Code: 6L5ZL09795Class: ACTIBQuantity: 12 [hp_X] in 59 mL
Cortisone acetateActive
Code: 883WKN7W8XClass: ACTIBQuantity: 12 [hp_X] in 59 mL
euphrasia strictaActive
Code: C9642I91WLClass: ACTIBQuantity: 12 [hp_X] in 59 mL
galphimia glauca flowering topActive
Code: 93PH5Q8M7EClass: ACTIBQuantity: 12 [hp_X] in 59 mL
HistamineActive
Code: 3POA0Q644UClass: ACTIBQuantity: 12 [hp_X] in 59 mL
juglans cinerea branch bark/root barkActive
Code: 48FZ1BHO18Class: ACTIBQuantity: 12 [hp_X] in 59 mL
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIMQuantity: 12 [hp_X] in 59 mL
nasturtium officinaleActive
Code: YH89GMV676Class: ACTIBQuantity: 12 [hp_X] in 59 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 12 [hp_X] in 59 mL
toxicodendron pubescens leafActive
Code: 6IO182RP7AClass: ACTIBQuantity: 12 [hp_X] in 59 mL
schoenocaulon officinale seedActive
Code: 6NAF1689IOClass: ACTIBQuantity: 12 [hp_X] in 59 mL
sassafras albidum root barkActive
Code: XC5UMP9I5FClass: ACTIBQuantity: 12 [hp_X] in 59 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0TClass: IACT
ORANGE PEELInactive
Code: TI9T76XD44Class: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Cyclic adenosine phosphateActive
Code: E0399OZS9NClass: ACTIBQuantity: 12 [hp_X] in 59 mL
Chicory leafActive
Code: 090CTY533NClass: ACTIBQuantity: 12 [hp_X] in 59 mL
Mucuna pruriens seedActive
Code: 3E271BSI0CClass: ACTIBQuantity: 12 [hp_X] in 59 mL
Saccharomyces cerevisiaeActive
Code: J17GBZ5VGXClass: ACTIBQuantity: 12 [hp_X] in 59 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

INDICATIONS & USAGE SECTION

Uses

Uses for temporary relief of allergy symptomse commonly
experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC,
SC, TN, VA, WV:

Itchy, watery eyes

Runny nose

Sneezing

Sore throat

Sinus congestion

Cough

Stuffy nose

Fatigue

Itchy, irritated skin

Hoarseness

Headache

as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

Reference image:Southern U.S.jpg

DOSAGE & ADMINISTRATION SECTION

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3
times per day.

Consult a physician for use in
children under 6 years of age.

Use additionally as needed, up
to 6 times per day.

Reference image:Southern U.S.jpg

WARNINGS SECTION

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Southern U.S.jpg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies unless otherwise noted.

Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Arum triphyllum, Arundo mauritanica, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Nasturtium aquaticum, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale.

HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Reference image:Southern U.S.jpg

OTC - PURPOSE SECTION

Active ingredients Purpose †

Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies.

Adenosinum cyclophosphoricum................headache, runny nose
Adrenalinum ..............hay fever, swollen sinuses, lung congestion
Adrenocorticotrophin (30X) ............................congestion, cough
Allium cepa...........................hay fever, sinus headache, sneezing
Alnus serrulata ..........................................hay fever, bronchitis
Arum triphyllum ............inflammation of nasal mucus membranes
Arundo mauritanica .........................nasal congestion and itching
Carduus benedictus ............................................tickling in nose
Cichorium intybus...........................................fatigue, headache
Cortisone aceticum.............................allergic reaction, irritability
Dolichos pruriens.......................................sore throat, itchy skin
Euphrasia officinalis.........................discharge from eyes and nose
Galphimia glauca.................................... puffy eyelids, hay fever
Histaminum hydrochloricum ....................coughing, itching throat
Juglans cinerea ............................red eyes, sneezing, sore throat
Kali muriaticum.......................................hoarseness, stuffy nose
Nasturtium aquaticum ......................sensitivity to cigarette toxins
Natrum muriaticum ...................................watery eyes, sneezing
Rhus tox .............................dry cough, sneezing, swelling of nose
RNA................................................................allergic reactions
Sabadilla..................................sore throat, runny nose, sneezing
Sassafras officinale .............................. minor breathing difficulty

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Southern U.S.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Southern U.S.jpg

OTHER SAFETY INFORMATION

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image:Southern U.S.jpg

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Southern U.S.jpg

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