MedPath

Reflux

Drug Facts:

Approved
Approval ID

69e9d842-6666-4d82-8237-18804b67b772

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.

Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Nadidum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur, Origanum Vulgare, Duodenum (Suis), Esophagus (Suis), Funiculus Umbilicalis Suis, Stomach (Suis), Nux Vomica, Coumarinum, Erythraea Centaurium, Pepsinum, Muriaticum Acidum, Citricum Acidum, Formicum Acidum, Sarcolacticum Acidum, Proteus (Morgani)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-1324
Product Classification
G
Generic Name
Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Nadidum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur, Origanum Vulgare, Duodenum (Suis), Esophagus (Suis), Funiculus Umbilicalis Suis, Stomach (Suis), Nux Vomica, Coumarinum, Erythraea Centaurium, Pepsinum, Muriaticum Acidum, Citricum Acidum, Formicum Acidum, Sarcolacticum Acidum, Proteus (Morgani)
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (23)

ACETYL COENZYME AActive
Quantity: 6 [hp_C] in 1 mL
Code: 76Q83YLO3O
Classification: ACTIB
NADIDEActive
Quantity: 6 [hp_C] in 1 mL
Code: 0U46U6E8UK
Classification: ACTIB
SILVER NITRATEActive
Quantity: 6 [hp_C] in 1 mL
Code: 95IT3W8JZE
Classification: ACTIB
IPECACActive
Quantity: 6 [hp_C] in 1 mL
Code: 62I3C8233L
Classification: ACTIB
ROBINIA PSEUDOACACIA BARKActive
Quantity: 6 [hp_C] in 1 mL
Code: 7TPC058OWY
Classification: ACTIB
SULFURActive
Quantity: 6 [hp_C] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
OREGANOActive
Quantity: 6 [hp_C] in 1 mL
Code: 0E5AT8T16U
Classification: ACTIB
SUS SCROFA DUODENUMActive
Quantity: 8 [hp_C] in 1 mL
Code: P6J2SFT80O
Classification: ACTIB
SUS SCROFA ESOPHAGUSActive
Quantity: 8 [hp_C] in 1 mL
Code: 81FZ7X4MWD
Classification: ACTIB
SUS SCROFA UMBILICAL CORDActive
Quantity: 8 [hp_C] in 1 mL
Code: 118OYG6W3H
Classification: ACTIB
SUS SCROFA STOMACHActive
Quantity: 8 [hp_C] in 1 mL
Code: T0920P9Z9A
Classification: ACTIB
COUMARINActive
Quantity: 8 [hp_C] in 1 mL
Code: A4VZ22K1WT
Classification: ACTIB
CENTAURIUM ERYTHRAEAActive
Quantity: 10 [hp_C] in 1 mL
Code: 57X4TSH58S
Classification: ACTIB
PEPSINActive
Quantity: 12 [hp_C] in 1 mL
Code: GID333S43J
Classification: ACTIB
PROTEUS MORGANIIActive
Quantity: 30 [hp_C] in 1 mL
Code: 56X6LID5ZY
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROCHLORIC ACIDActive
Quantity: 6 [hp_C] in 1 mL
Code: QTT17582CB
Classification: ACTIB
ANHYDROUS CITRIC ACIDActive
Quantity: 6 [hp_C] in 1 mL
Code: XF417D3PSL
Classification: ACTIB
FORMIC ACIDActive
Quantity: 6 [hp_C] in 1 mL
Code: 0YIW783RG1
Classification: ACTIB
LACTIC ACID, L-Active
Quantity: 6 [hp_C] in 1 mL
Code: F9S9FFU82N
Classification: ACTIB
ADENOSINE TRIPHOSPHATE DISODIUMActive
Quantity: 6 [hp_C] in 1 mL
Code: 5L51B4DR1G
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 8 [hp_C] in 1 mL
Code: 269XH13919
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/20/2018

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-1324-1

HOMEOPATHIC

REFLUX

1 FL OZ (30 ml)

Reflux

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/20/2018

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to heartburn and esophageal reflux.**

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/20/2018

ACTIVE INGREDIENTS:

Acetyl Coenzyme A 6X, 8X, Adenosinum Triphosphoricum Dinatrum 6X, 8X, Nadidum 6X, 8X, Argentum Nitricum 6X, 10X, Ipecacuanha 6X, 10X, Robinia Pseudoacacia 6X, 10X, Sulphur 6X, 10X, Origanum Vulgare 6X, 10X, 30X, Duodenum (Suis) 8X, Esophagus (Suis) 8X, Funiculus Umbilicalis Suis 8X, Stomach (Suis) 8X, Nux Vomica 8X, 10X, 30X, Coumarinum 8X, 10X, 30X, 200X, Erythraea Centaurium 10X, 30X, Pepsinum 12X, Muriaticum Acidum 6C, 12C, 30C, 200C, Citricum Acidum 6C, 12C, 30C, 200C, Formicum Acidum 6C, 12C, 30C, 200C, Sarcolacticum Acidum 6C, 12C, 30C, 200C, Proteus (Morgani) 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/20/2018

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to heartburn and esophageal reflux.**

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

WARNINGS SECTION

LOINC: 34071-1Updated: 9/20/2018

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or a 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/20/2018

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/20/2018

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/20/2018

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/20/2018

QUESTIONS:

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

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Reflux - FDA Drug Approval Details