FDA.reportPublic FDA data

Oxaltem

Manufacturer
Nucleic Products, LLC | Apotheca Company
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:26:58

Label at a glance#

ProductOxaltem
Active ingredientBERBERIS VULGARIS ROOT BARK, OXALIC ACID, SANGUINARIA CANADENSIS WHOLE, CHIMAPHILA UMBELLATA WHOLE, CALCIUM FLUORIDE, CALCIUM SILICATE, URIC ACID, TRIBASIC CALCIUM PHOSPHATE, PARATHYROID HORMONE, PYRIDOXINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Berberis Vulgaris 6X, 9X, 12X, Oxalicum Acidum 6X, 9X, 12X, 30C, Sanguinaria Canadensis 9X, Chimaphila Umbellata 9X, 30C, Calcarea Fluorica 12X 30C, Calcarea Silicata 12X 30C, Uricum Acidum 12X, 30C, Calcarea Phosphorica 6C, 9C, 30C, Parathormonum 9C, Pyridoxinum Hydrochloricum 12C,

INDICATIONS:

OTC - PURPOSE SECTION

Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.

Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

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

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

Do not use if seal is broken or missing.

This Product does not contain sugar, starch, salt, preservatives, artificial flavors or additives, and no wheat, gluten, soy or milk derivatives.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.

Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% organic ethanol, purified water

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by: Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 75053-0009-1

Nu cleic

Oxaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

OxaltemOxaltem

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a0139244-df6d-41aa-899a-9c06b76d61f2Product name120150318
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75053-0009-1Oxaltem118 mL in 1 BOTTLE, DROPPERLIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75053-0009OXALTEM (BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM) LIQUID [NUCLEIC PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20240514_ab35fadf-5213-486b-b313-e676420efff7.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75053-000975053-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
OXALIC ACID9E7R5L6H31ACTIB
SANGUINARIA CANADENSIS WHOLEB3XJA0OV6TACTIB
CHIMAPHILA UMBELLATA WHOLEWCK21A9W9JACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALCIUM SILICATES4255P4G5MACTIB
URIC ACID268B43MJ25ACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
PARATHYROID HORMONEN19A0T0E5JACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
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
OxaltemBERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUMNucleic Products, LLCab35fadf-5213-486b-b313-e676420efff72024-05-13WarningsExact identifier
ndc (package): 75053-0009-1
ndc (product): 75053-0009
ndc11 (package): 75053000901
spl id: 6ebc0f64-a4ad-45a3-9711-34ed4190a1e2
spl set id: ab35fadf-5213-486b-b313-e676420efff7

Reported adverse events (FAERS/openFDA)#

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