FDA.reportPublic FDA data

Regional Allergies Hawaii U.S.™

Manufacturer
King Bio Inc.
Effective date
2016-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:44

Label at a glance#

ProductRegional Allergies Hawaii U.S.
Active ingredientADENOSINE CYCLIC PHOSPHATE, EPINEPHRINE, CORTICOTROPIN, ONION, CORTISONE ACETATE, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, POTASSIUM CHLORIDE, SUS SCROFA NASAL MUCOSA, SODIUM CHLORIDE, SACCHAROMYCES CEREVISIAE RNA, SCHOENOCAULON OFFICINALE SEED
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla​​. Equal volumes of each ingredient in 12X, 30X, LM1 potencies.

INDICATIONS & USAGE SECTION

Uses ​for temporary relief of symptoms: itchy, watery eyes, sore throat, cough, sneezing.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 6-12: 2 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of symptoms:

  • itchy
  • watery eyes
  • sore throat
  • cough
  • sneezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5206-22020-01-31C16284748780-19d75b9d0-4b88-f424-e053-dadaa90a57ceRegional Allergies Hawaii U.S.™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5206-2Regional Allergies Hawaii U.S.59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5206REGIONAL ALLERGIES HAWAII U.S. (ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, ADRENOCORTICOTROPHIN, ALLIUM CEPA, CORTISONE ACETICUM, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, MUCOSA NASALIS SUIS, NATRUM MURIATICUM, RNA, SABADILLA) LIQUID [KING BIO INC.]2Legacy NDC, 1 package rows20160412_38363b9e-2f1f-4b6b-bb7c-c68c763344dc.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-520657955-5206-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINE CYCLIC PHOSPHATEE0399OZS9NACTIB
EPINEPHRINEYKH834O4BHACTIB
CORTICOTROPINK0U68Q2TXAACTIB
ONION492225Q21HACTIB
CORTISONE ACETATE883WKN7W8XACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIM
SUS SCROFA NASAL MUCOSAID3Z1X61WYACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SACCHAROMYCES CEREVISIAE RNAJ17GBZ5VGXACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6a204348-130e-446a-8d0f-f5a5c64f772238363b9e-2f1f-4b6b-bb7c-c68c763344dc2016-04-11WarningsExact identifier
spl id: 6a204348-130e-446a-8d0f-f5a5c64f7722
spl set id: 38363b9e-2f1f-4b6b-bb7c-c68c763344dc

Reported adverse events (FAERS/openFDA)#

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