R09

Product NDC
63479-1809
11-digit product format
634791809
Labeler code
63479
Product ID
63479-1809_0e76ea05-c3d4-8465-e063-6294a90a747f
Type
HUMAN OTC DRUG
Nonproprietary name
ADENOSINE TRIPHOSPHATE, BAPTISIA TINCTORIA ROOT, CEANOTHUS AMERICANUS LEAF, FUCUS VESICULOSUS, PODOPHYLLUM RESIN, SEPIA OFFICINALIS JUICE, TESTOSTERONE
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1986-03-15
Substance
ADENOSINE TRIPHOSPHATE; BAPTISIA TINCTORIA ROOT; CEANOTHUS AMERICANUS LEAF; FUCUS VESICULOSUS; PODOPHYLLUM RESIN; SEPIA OFFICINALIS JUICE; TESTOSTERONE
Active strength
5; 4; 7; 4; 6; 1; 4 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
R09
Brand name suffix
SPLEEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE4 [hp_C]/mL
ADENOSINE TRIPHOSPHATE5 [hp_X]/mL
BAPTISIA TINCTORIA ROOT4 [hp_C]/mL
PODOPHYLLUM RESIN6 [hp_X]/mL
CEANOTHUS AMERICANUS LEAF7 [hp_C]/mL
FUCUS VESICULOSUS4 [hp_C]/mL
SEPIA OFFICINALIS JUICE1 [hp_Q]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3XMK78S47OInternal UNII lookup
8L70Q75FXEInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
16902YVY2BInternal UNII lookup
25B1Y14T8NInternal UNII lookup
535G2ABX9MInternal UNII lookup
QDL83WN8C2Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb8b301d-0048-16bd-e053-2a95a90a045aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1809-1R09SPLEEN30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1809R09 SPLEEN (ADENOSINE TRIPHOSPHATE, BAPTISIA TINCTORIA ROOT, CEANOTHUS AMERICANUS LEAF, FUCUS VESICULOSUS, PODOPHYLLUM RESIN, SEPIA OFFICINALIS JUICE, TESTOSTERONE) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bb8b301d-0048-16bd-e053-2a95a90a045a.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
R09 SPLEENADENOSINE TRIPHOSPHATE, BAPTISIA TINCTORIA ROOT, CEANOTHUS AMERICANUS LEAF, FUCUS VESICULOSUS, PODOPHYLLUM RESIN, SEPIA OFFICINALIS JUICE, TESTOSTERONEApex Energetics Inc.bb8b301d-0048-16bd-e053-2a95a90a045a2024-01-08WarningsExact identifier
ndc (product): 63479-1809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1809-16347918090130 mL in 1 BOTTLE, GLASS (63479-1809-1) 30 ml1986-03-150000-00-00NoNoCurrent