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
IngredientStrength
BERBERIS VULGARIS ROOT BARK6 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
CALCIUM SILICATE12 [hp_X]/mL
CHIMAPHILA UMBELLATA WHOLE9 [hp_X]/mL
OXALIC ACID6 [hp_X]/mL
PARATHYROID HORMONE9 [hp_C]/mL
PYRIDOXINE HYDROCHLORIDE12 [hp_C]/mL
SANGUINARIA CANADENSIS WHOLE9 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE6 [hp_C]/mL
URIC ACID12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, O3B55K4YKI, S4255P4G5M, WCK21A9W9J, 9E7R5L6H31, N19A0T0E5J, 68Y4CF58BV, B3XJA0OV6T, 91D9GV0Z28, 268B43MJ25

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75053-0009-175053000901118 mL in 1 BOTTLE, DROPPER (75053-0009-1) 118 ml2022-01-312028-07-26NoNoCurrent