FDA.reportPublic FDA data

Male Endocrine Axis Drops

Product NDC
63083-5019
11-digit product format
630835019
Labeler code
63083
Product ID
63083-5019_49b66718-9b89-4dd2-a96b-b146f620af82
Type
HUMAN OTC DRUG
Nonproprietary name
Male Endocrine Axis Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS PROSTATE GLAND; BOS TAURUS TESTICLE; FERRIC CATION; POPULUS TREMULOIDES BARK; PYGEUM; SAW PALMETTO; SELENIUM; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; TURNERA DIFFUSA LEAFY TWIG; ZINC
Active strength
6; 6; 6; 6; 1; 3; 1; 6; 3; 2; 6; 4; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Male Endocrine Axis Drops
Brand name suffix
5019
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOS TAURUS PITUITARY GLAND, POSTERIOR6 [hp_X]/59mL
BOS TAURUS PROSTATE GLAND6 [hp_X]/59mL
BOS TAURUS TESTICLE6 [hp_X]/59mL
FERRIC CATION6 [hp_X]/59mL
POPULUS TREMULOIDES BARK1 [hp_X]/59mL
PYGEUM3 [hp_X]/59mL
SAW PALMETTO1 [hp_X]/59mL
SELENIUM6 [hp_X]/59mL
SMILAX ORNATA ROOT3 [hp_X]/59mL
SOLIDAGO VIRGAUREA FLOWERING TOP2 [hp_X]/59mL
SUS SCROFA ADRENAL GLAND6 [hp_X]/59mL
TURNERA DIFFUSA LEAFY TWIG4 [hp_X]/59mL
ZINC3 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7JM57I419K, 1P66FXU2MW, PR4RXL6G2H, 91O4LML611, 5543O0CEID, 709HYI14M4, J7WWH9M8QS, H6241UJ22B, 2H1576D5WG, 5405K23S50, 398IYQ16YV, RQ2CFA7WWJ, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-5019-22026-01-08C16284748780-11030e365-14ad-111a-e063-dadaa90a10e2HMEA
63083-5019-22026-01-08C16284748780-11030e365-14ad-111a-e063-dadaa90a10e2HMEA
63083-5019-22024-01-30C16284748780-11030e365-14ad-111a-e063-dadaa90a10e2HMEA
63083-5019-22024-01-30C16284748780-11030e365-14ad-111a-e063-dadaa90a10e2HMEA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-5019-2Male Endocrine Axis Drops501959 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-5019MALE ENDOCRINE AXIS DROPS 5019 (MALE ENDOCRINE AXIS DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_607dd42d-5b41-4c0a-8499-83763dc04ad1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-5019-26308350190259 mL in 1 BOTTLE, DROPPER (63083-5019-2) 59 ml1985-08-150000-00-00NoNoCurrent