FDA.reportPublic FDA data

C08

Product NDC
63479-0308
Requested package NDC
63479-0308-1
11-digit product format
634790308
Labeler code
63479
Product ID
63479-0308_0e76d80a-2d15-e4c4-e063-6294a90aeac2
Type
HUMAN OTC DRUG
Nonproprietary name
ABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN D
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1988-08-15
Substance
ABIES ALBA LEAFY TWIG; BOS TAURUS GALLSTONE; CALCIUM ACETATE; CALCIUM ARSENATE; CALCIUM CHLORIDE; CALCIUM FLUORIDE; CALCIUM HEXAFLUOROSILICATE; CALCIUM HYPOPHOSPHITE; CALCIUM IODIDE; CALCIUM OXALATE MONOHYDRATE; CALCIUM PICRATE; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHOLESTEROL; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SULFUR IODIDE; SUS SCROFA PARATHYROID GLAND; TRIBASIC CALCIUM PHOSPHATE; URTICA URENS; VITAMIN D
Active strength
8; 15; 12; 8; 12; 15; 12; 12; 12; 12; 12; 12; 15; 6; 15; 6; 6; 15; 12; 12; 9; 15; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calcium [CS], Calcium [CS], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
C08
Brand name suffix
CALCIUM METABOLISM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIES ALBA LEAFY TWIG8 [hp_X]/mL
CALCIUM ACETATE15 [hp_X]/mL
CALCIUM HYPOPHOSPHITE12 [hp_X]/mL
CALCIUM CHLORIDE8 [hp_X]/mL
CALCIUM OXALATE MONOHYDRATE12 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE15 [hp_X]/mL
CALCIUM PICRATE12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]/mL
CALCIUM HEXAFLUOROSILICATE12 [hp_X]/mL
SULFUR IODIDE12 [hp_X]/mL
BOS TAURUS GALLSTONE12 [hp_X]/mL
URTICA URENS12 [hp_X]/mL
VITAMIN D15 [hp_X]/mL
CHOLESTEROL6 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CALCIUM ARSENATE6 [hp_X]/mL
CALCIUM IODIDE6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
CALCIUM FLUORIDE9 [hp_C]/mL
SUS SCROFA PARATHYROID GLAND15 [hp_X]/mL
COMFREY ROOT12 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CE3G3J56LRInternal UNII lookup
Y882YXF34XInternal UNII lookup
CUI83R2732Internal UNII lookup
M4I0D6VV5MInternal UNII lookup
4PP86KK527Internal UNII lookup
91D9GV0Z28Internal UNII lookup
53D441QVT8Internal UNII lookup
18E7415PXQInternal UNII lookup
2NVP93XVQ3Internal UNII lookup
L6L8KA2AA0Internal UNII lookup
4162LZ0N4OInternal UNII lookup
IHN2NQ5OF9Internal UNII lookup
9VU1KI44GPInternal UNII lookup
97C5T2UQ7JInternal UNII lookup
1MBW07J51QInternal UNII lookup
95OX15I8ZUInternal UNII lookup
8EKI9QEE2HInternal UNII lookup
2E32821G6IInternal UNII lookup
T7S323PKJSInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd09a34f-1615-09f0-e053-2995a90ac2efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0308-1C08CALCIUM METABOLISM30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0308C08 CALCIUM METABOLISM (ABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN D) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bd09a34f-1615-09f0-e053-2995a90ac2ef.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
ndc (package): 63479-0308-1
ndc (product): 63479-0308
ndc11 (package): 63479030801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0308-16347903080130 mL in 1 BOTTLE, GLASS (63479-0308-1) 30 ml1988-08-150000-00-00NoNoCurrent