FDA.reportPublic FDA data

Addiclenz

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2022-05-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:17:25

Label at a glance#

ProductAddiclenz
Active ingredientBETA VULGARIS, PEUMUS BOLDUS LEAF, CHELIDONIUM MAJUS, PETROSELINUM CRISPUM, TARAXACUM OFFICINALE, ARSENIC TRIOXIDE, BISPHENOL A, COBALT, COPPER, GLYPHOSATE, IODINE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, SELENIUM, ZINC, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALDEHYDE, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Beta Vulgaris 3X, Boldo 3X, Chelidonium Majus 3X, Petroselinum Sativum 3X, Taraxacum Officinale 3X, Arsenicum Album 12X, Bisphenol A 12X, Cobaltum Metallicum 12X, Cuprum Metallicum 12X, Glyphosate 12X, Iodium 12X, Lycopodium Clavatum 12X, Phosphoricum Acidum 12X, Selenium Metallicum 12X, Zincum Metallicum 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methyl Paraben 30X, Propyl Paraben 30X, Sodium Benzoate 30X, Sodium Citrate 30X, Titanium Dioxide 30X, Zincum Oxydatum 30X.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, occasional diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

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

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, occasional diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070   www.desbio.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO
NDC 43742-1558-1
HOMEOPATHIC
ADDICLENZ
1 FL OZ (30 ml)

AddiclenzAddiclenz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-1558-1Addiclenz30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-1558ADDICLENZ (BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM) LIQUID [DESERET BIOLOGICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20220513_e39235ea-2a2f-44a7-92d6-fb1d428ebabd.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-155843742-1558-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA VULGARIS4G174V5051ACTIB
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
PETROSELINUM CRISPUM1WZA4Y92EXACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BISPHENOL AMLT3645I99ACTIB
COBALT3G0H8C9362ACTIB
COPPER789U1901C5ACTIB
GLYPHOSATE4632WW1X5AACTIB
IODINE9679TC07X4ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SELENIUMH6241UJ22BACTIB
ZINCJ41CSQ7QDSACTIB
ASPARTAMEZ0H242BBR1ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FORMALDEHYDE1HG84L3525ACTIB
METHYLENE CHLORIDE588X2YUY0AACTIB
METHYLPARABENA2I8C7HI9TACTIB
PROPYLPARABENZ8IX2SC1OHACTIB
SODIUM BENZOATEOJ245FE5EUACTIB
SODIUM CITRATE1Q73Q2JULRACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
ndc (package): 43742-1558-1
ndc (product): 43742-1558
ndc11 (package): 43742155801
spl id: 4be4bd6f-aa0b-46e1-8e57-ba38a4fb86e1
spl set id: e39235ea-2a2f-44a7-92d6-fb1d428ebabd

Reported adverse events (FAERS/openFDA)#

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