FDA.reportPublic FDA data

Fragrance and Phenolic Allergy Relief

Manufacturer
King Bio Inc.
Effective date
2016-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:33

Label at a glance#

ProductFragrance and Phenolic Allergy Relief
Active ingredientACETALDEHYDE, ARSENIC TRIOXIDE, BALSAM PERU, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, COUMARIN, SAFFRON, HISTAMINE DIHYDROCHLORIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, SEPIA OFFICINALIS JUICE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium maculatum, Coumarinum, Corcus sativus, Histaminum hydrochloricum, Lachesis mutus, Lycopodium clavatum, Phosphorus, Sepia. Equal volumes of each ingredient in 12X, 24X, and LM1 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of: respiratory irritations, irritation of skin, eyes and mucous membranes, headache, lethargy, nausea, mood swings.

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 2-12 years: 2 sprays 3 times per day.

OTHER SAFETY INFORMATION

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

OTC - PURPOSE SECTION

Uses for temporary relief of:

  • respiratory irritations
  • irritation of skin, eyes and mucous membranes
  • headache
  • lethargy
  • nausea
  • mood swings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6486-22020-01-31C16284748780-19d75b9d0-e248-f424-e053-dadaa90a57ceFragrance and Phenolic Allergy Relief™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6486-2Fragrance and Phenolic Allergy Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6486FRAGRANCE AND PHENOLIC ALLERGY RELIEF (ACETALDEHYDE, ARSENICUM ALBUM, BALSAMUM PERUVIANUM, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CONIUM MACULATUM, COUMARINUM, CROCUS SATIVUS, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PHOSPHORUS, SEPIA) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160318_0706e273-3922-4ddc-a060-3142e1fd4527.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-648657955-6486-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETALDEHYDEGO1N1ZPR3BACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BALSAM PERU8P5F881OCYACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
COUMARINA4VZ22K1WTACTIB
SAFFRONE849G4X5YJACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
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
14986699-3690-4c0d-927f-8e79abf466420706e273-3922-4ddc-a060-3142e1fd45272016-03-18WarningsExact identifier
spl id: 14986699-3690-4c0d-927f-8e79abf46642
spl set id: 0706e273-3922-4ddc-a060-3142e1fd4527

Reported adverse events (FAERS/openFDA)#

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