FDA.reportPublic FDA data

ADENOSINE CYCLIC PHOSPHATE

Manufacturer
King Bio Inc.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:48:54

Label at a glance#

ProductAllergies Great Lakes U.S.
Active ingredientADENOSINE CYCLIC PHOSPHATE, EPINEPHRINE, CORTICOTROPIN, ONION, AMBROSIA ARTEMISIIFOLIA WHOLE, ARISAEMA TRIPHYLLUM ROOT, ARUNDO PLINIANA ROOT, CHELIDONIUM MAJUS WHOLE, CHENOPODIUM VULVARIA WHOLE, CHICORY ROOT, CORTISONE ACETATE, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HEDERA HELIX FLOWERING TWIG, HISTAMINE DIHYDROCHLORIDE, JUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM CHLORIDE, SODIUM CHLORIDE, PULSATILLA VULGARIS WHOLE, SACCHAROMYCES CEREVISIAE RNA, SCHOENOCAULON OFFICINALE SEED, TEUCRIUM SCORODONIA FLOWERING TOP
Label structure9 sections

Indications and uses

For temporary relief of: itchy, watery eyes, sore throat, runny nose, congestion.  Reference image: Great Lakes.jpg

Dosage and administration

Initially, depress pump until primed. Spray one dose directly into mouth. Adults: 3 sprays 3 times per day. Children (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: Great Lakes.jpg

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Stop use and ask your doctor if symptoms
persist or worsen.

If pregnant or breast-feeding, take only on
advice of a healthcare professional.

Keep out of reach of children.

Reference image: Great Lakes.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image: Great Lakes.jpg

Directions

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until
primed.

Spray one dose directly into mouth.

Adults: 3 sprays 3 times per day.

Children (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: Great Lakes.jpg

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use
only if seal is intact. This product has not been
clinically tested.

King Bio, Inc. FDA Reg. #1053442
3 Westside Dr. Asheville, NC 28806 USA
Questions? Call 866.298.2740

Reference image: Great Lakes.jpg

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Adenosinum cyclophosphoricum, Adrenalinum,
Adrenocorticotrophin (30X, 100X), Allium cepa,
Ambrosia, Arum triph, Arundo, Chelidonium maj,
Chenopodium vul, Cichorium int, Cortisone
aceticum, Euphrasia, Galphimia, Hedera,
Histaminum hydrochloricum, Juglans cin, Kali mur,
Nat mur, Pulsatilla, RNA, Sabadilla, Teucrium scor.


Equal volumes of each HPUS ingredient in 12X,
30X, 100X, 1LM, 2LM, 3LM, 5LM potencies, unless otherwise noted.

Reference image: Great Lakes.jpg

Uses

INDICATIONS & USAGE SECTION

For temporary relief of: itchy, watery eyes,
sore throat, runny nose, congestion. 

Reference image: Great Lakes.jpg

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Reference image: Great Lakes.jpg

OTC - PURPOSE SECTION

Uses for temporary relief of: 

itchy, watery eyes

sore throat

runny nose

congestion

Refernce image: Great Lakes.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description Great Lakes.jpgimage description Great Lakes.jpg

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-372457955-3724-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINE CYCLIC PHOSPHATEE0399OZS9NACTIB
EPINEPHRINEYKH834O4BHACTIB
CORTICOTROPINK0U68Q2TXAACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA WHOLE9W34L2CQ9AACTIB
ARISAEMA TRIPHYLLUM ROOTDM64K844DMACTIB
ARUNDO PLINIANA ROOTZXE7LB03WCACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
CHENOPODIUM VULVARIA WHOLE0VSD1H8IW4ACTIB
CHICORY ROOT090CTY533NACTIB
CORTISONE ACETATE883WKN7W8XACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
HEDERA HELIX FLOWERING TWIG3D10KUA6BMACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
JUGLANS CINEREA BRANCH BARK/ROOT BARK48FZ1BHO18ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SACCHAROMYCES CEREVISIAE RNAJ17GBZ5VGXACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
TEUCRIUM SCORODONIA FLOWERING TOPLOK3I16O7GACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
ORANGE PEELTI9T76XD44IACT
CITRUS RETICULATA FRUIT OIL25P9H3QU5EIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
POLYEPSILON-LYSINE (4000 MW)WB0M8X4TWRIACT
CARYA OVATA BARKX765CF609LIACT
STEVIOL4741LYX6RTIACT

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
12152edb-b149-4d39-916d-eb8278bb66912303b900-1346-41c7-bf35-2ad5debed35e2025-05-16WarningsExact identifier
spl set id: 2303b900-1346-41c7-bf35-2ad5debed35e

Reported adverse events (FAERS/openFDA)#

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