Home FDA labels cca66126-69ba-4d64-967b-dcff9af2bc05 Oxaltem openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Oxaltem
Generic name BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM
Manufacturer Nucleic Products, LLC
Product type HUMAN OTC DRUG
SPL set ID 3670be1f-59d1-44ce-b6ef-c8c1bcf25a1e
SPL ID cca66126-69ba-4d64-967b-dcff9af2bc05
Version 2
Effective date 2025-11-24
Source export date 2026-09-28
Source partition 14
Source file https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:40:33 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 18 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name Oxaltem openfda.brand_name generic name BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM openfda.generic_name manufacturer name Nucleic Products, LLC openfda.manufacturer_name ndc package 75053-0012-1 openfda.package_ndc ndc product 75053-0012 openfda.product_ndc ndc11 package 75053001201 derived:openfda.package_ndc spl id cca66126-69ba-4d64-967b-dcff9af2bc05 id spl set id 3670be1f-59d1-44ce-b6ef-c8c1bcf25a1e set_id unii N19A0T0E5J openfda.unii unii 0K2L2IJ59O openfda.unii unii 268B43MJ25 openfda.unii unii O3B55K4YKI openfda.unii unii WCK21A9W9J openfda.unii unii 1TH8Q20J0U openfda.unii unii 91D9GV0Z28 openfda.unii unii 68Y4CF58BV openfda.unii unii S4255P4G5M openfda.unii unii N9288CD508 openfda.unii
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS: As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if: Symptoms persist for more than 7 days or worsen. Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately. Do not use if seal is broken or missing. This Product does not contain sugar, starch, preservatives, artificial flavors or additives, and no wheat, gluten, soy, or milk derivatives.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.