Home NDC 75053-0009 Oxaltem
Product NDC 75053-0009
11-digit product format 750530009
Labeler code 75053
Product ID 75053-0009_6ebc0f64-a4ad-45a3-9711-34ed4190a1e2
Type HUMAN OTC DRUG
Nonproprietary name Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum
Dosage form LIQUID
Route ORAL
Labeler Nucleic Products, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-01-31
Marketing end 2028-07-26
Substance BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CALCIUM SILICATE; CHIMAPHILA UMBELLATA WHOLE; OXALIC ACID; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE; SANGUINARIA CANADENSIS WHOLE; TRIBASIC CALCIUM PHOSPHATE; URIC ACID
Active strength 6; 12; 12; 9; 6; 9; 12; 9; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Oxaltem Active Ingredients# Ingredient, Strength table Ingredient Strength BERBERIS VULGARIS ROOT BARK 6 [hp_X]/mL OXALIC ACID 6 [hp_X]/mL SANGUINARIA CANADENSIS WHOLE 9 [hp_X]/mL CHIMAPHILA UMBELLATA WHOLE 9 [hp_X]/mL CALCIUM FLUORIDE 12 [hp_X]/mL CALCIUM SILICATE 12 [hp_X]/mL URIC ACID 12 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE 6 [hp_C]/mL PARATHYROID HORMONE 9 [hp_C]/mL PYRIDOXINE HYDROCHLORIDE 12 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75053-0009-1 Oxaltem 118 mL in 1 BOTTLE, DROPPER LIQUID 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75053-0009 OXALTEM (BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM) LIQUID [NUCLEIC PRODUCTS, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240514_ab35fadf-5213-486b-b313-e676420efff7.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxaltem BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM Nucleic Products, LLC ab35fadf-5213-486b-b313-e676420efff7 2024-05-13 Warnings Exact identifier ndc (product): 75053-0009
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75053-0009-1 75053000901 118 mL in 1 BOTTLE, DROPPER (75053-0009-1) 118 ml 2022-01-31 2028-07-26 No No Current