IMMUNO-REG Formula

Product NDC
63479-2532
11-digit product format
634792532
Labeler code
63479
Product ID
63479-2532_0e7735ff-acf7-c569-e063-6294a90a29c0
Type
HUMAN OTC DRUG
Nonproprietary name
BETULA PENDULA, FOLIA, BOS TAURUS THYMUS, CASTANEA VESCA, POPLAR BUD, RIBES NIGRUM FLOWER BUD, RNA, VISCUM ALBUM STEM
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-22
Substance
POPULUS BALSAMIFERA LEAF BUD; VISCUM ALBUM STEM; BETULA PENDULA LEAF; BOS TAURUS THYMUS; CASTANEA SATIVA LEAF; RIBES NIGRUM FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA
Active strength
2; 1; 2; 7; 2; 1; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/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
IMMUNO-REG Formula
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POPULUS BALSAMIFERA LEAF BUD2 [hp_X]/mL
VISCUM ALBUM STEM1 [hp_X]/mL
BETULA PENDULA LEAF2 [hp_X]/mL
BOS TAURUS THYMUS7 [hp_C]/mL
CASTANEA SATIVA LEAF2 [hp_X]/mL
RIBES NIGRUM FLOWER BUD1 [hp_X]/mL
SACCHAROMYCES CEREVISIAE RNA4 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9CQ6C00G3CInternal UNII lookup
MDU02P1FZZInternal UNII lookup
5HW39H9KDHInternal UNII lookup
8XEJ88V2T8Internal UNII lookup
IV3S2HH53GInternal UNII lookup
VYH9Y9BCCPInternal UNII lookup
J17GBZ5VGXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8c79ec5-0848-8f6e-e053-2995a90a203eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-2532-1IMMUNO-REG Formula30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-2532IMMUNO-REG FORMULA (BETULA PENDULA, FOLIA, BOS TAURUS THYMUS, CASTANEA VESCA, POPLAR BUD, RIBES NIGRUM FLOWER BUD, RNA, VISCUM ALBUM STEM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_d8c79ec5-0848-8f6e-e053-2995a90a203e.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
IMMUNO-REG FormulaBETULA PENDULA, FOLIA, BOS TAURUS THYMUS, CASTANEA VESCA, POPLAR BUD, RIBES NIGRUM FLOWER BUD, RNA, VISCUM ALBUM STEMApex Energetics Inc.d8c79ec5-0848-8f6e-e053-2995a90a203e2024-01-08WarningsExact identifier
ndc (product): 63479-2532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-2532-16347925320130 mL in 1 BOTTLE, GLASS (63479-2532-1) 30 ml2022-03-220000-00-00NoNoCurrent