Oxaltem

Product NDC
75053-0012
11-digit product format
750530012
Labeler code
75053
Product ID
75053-0012_cca66126-69ba-4d64-967b-dcff9af2bc05
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
2024-05-21
Substance
BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CALCIUM SILICATE; CHIMAPHILA UMBELLATA WHOLE; OXALIC ACID DIHYDRATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE; SANGUINARIA CANADENSIS ROOT; 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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaltem
Listing expiration
2026-12-31

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 ACID DIHYDRATE6 [hp_X]/mL
PARATHYROID HORMONE9 [hp_C]/mL
PYRIDOXINE HYDROCHLORIDE12 [hp_C]/mL
SANGUINARIA CANADENSIS ROOT9 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE6 [hp_C]/mL
URIC ACID12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, O3B55K4YKI, S4255P4G5M, WCK21A9W9J, 0K2L2IJ59O, N19A0T0E5J, 68Y4CF58BV, N9288CD508, 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
75053-0012-1Oxaltem118 mL in 1 BOTTLE, DROPPERLIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75053-0012OXALTEM (BERBERIS VULGARIS, OXALICUM ACIDUM, SANGUINARIA CANADENSIS, CHIMAPHILA UMBELLATA, CALCAREA FLUORICA, CALCAREA SILICATA, URICUM ACIDUM, CALCAREA PHOSPHORICA, PARATHORMONUM, PYRIDOXINUM HYDROCHLORICUM) LIQUID [NUCLEIC PRODUCTS, LLC]1Current NDC, 1 package rows20240522_3670be1f-59d1-44ce-b6ef-c8c1bcf25a1e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75053-0012-175053001201118 mL in 1 BOTTLE, DROPPER (75053-0012-1) 118 ml2024-05-21NoNoHistorical