MedPath

Apiol

Drug Facts:

Approved
Approval ID

aea6b523-29fa-4392-ae57-d5038404fd47

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Deseret Biologicals, Inc.

DUNS: 940741853

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Apiolum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-0781
Product Classification
G
Generic Name
Apiolum
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (3)

APIOLE (PARSLEY)Active
Quantity: 6 [hp_X] in 1 mL
Code: QQ67504PXO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/29/2016

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-0781-1

HOMEOPATHIC

APIOL

1 FL OZ (30 ml)

Apiol

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/29/2016

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to Apiol sensitivity including joint pain, loose stools, stomach upset, menstrual cramps, headache, lack of menstrual periods, rash, and swollen tongue.**

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/29/2016

DIRECTIONS:

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/29/2016

ACTIVE INGREDIENTS:

Apiolum 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/29/2016

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to Apiol sensitivity including joint pain, loose stools, stomach upset, menstrual cramps, headache, lack of menstrual periods, rash, and swollen tongue.**

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

WARNINGS SECTION

LOINC: 34071-1Updated: 6/29/2016

WARNINGS:

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

If pregnant or breast-feeding, seek advice of a health professional before use.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/29/2016

KEEP OUT OF REACH OF CHILDREN:

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/29/2016

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/29/2016

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

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Apiol - FDA Drug Approval Details