PINEAL Formula

Product NDC
63479-2507
11-digit product format
634792507
Labeler code
63479
Product ID
63479-2507_0e775b4a-84f2-ff58-e063-6394a90a64f7
Type
HUMAN OTC DRUG
Nonproprietary name
BETULA PENDULA FOLIA, CASTANEA VESCA, POPLAR BUD, RNA, SUS SCROFA PINEAL GLAND
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-10-17
Substance
POPULUS BALSAMIFERA LEAF BUD; SACCHAROMYCES CEREVISIAE RNA; BETULA PENDULA LEAF; SUS SCROFA PINEAL GLAND; CASTANEA SATIVA LEAF
Active strength
2; 4; 2; 7; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
PINEAL Formula
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POPULUS BALSAMIFERA LEAF BUD2 [hp_X]/mL
SACCHAROMYCES CEREVISIAE RNA4 [hp_X]/mL
BETULA PENDULA LEAF2 [hp_X]/mL
SUS SCROFA PINEAL GLAND7 [hp_C]/mL
CASTANEA SATIVA LEAF2 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9CQ6C00G3CInternal UNII lookup
J17GBZ5VGXInternal UNII lookup
5HW39H9KDHInternal UNII lookup
050QZ2EDK7Internal UNII lookup
IV3S2HH53GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e99b03e4-f547-0b9b-e053-2a95a90a04b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-2507-1PINEAL Formula30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-2507PINEAL FORMULA (BETULA PENDULA FOLIA, CASTANEA VESCA, POPLAR BUD, RNA, SUS SCROFA PINEAL GLAND) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_e99b03e4-f547-0b9b-e053-2a95a90a04b5.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
PINEAL FormulaBETULA PENDULA FOLIA, CASTANEA VESCA, POPLAR BUD, RNA, SUS SCROFA PINEAL GLANDApex Energetics Inc.e99b03e4-f547-0b9b-e053-2a95a90a04b52024-01-08WarningsExact identifier
ndc (product): 63479-2507

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-2507-16347925070130 mL in 1 BOTTLE, GLASS (63479-2507-1) 30 ml2022-10-170000-00-00NoNoCurrent