FDA.reportPublic FDA data

Cerebellutem

Manufacturer
Nucleic Products, LLC | Apotheca Company
Effective date
2025-04-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:33:12

Label at a glance#

ProductCerebellutem
Active ingredientCAUSTICUM, WORMWOOD, RANUNCULUS GLACIALIS WHOLE, THERIDION CURASSAVICUM, HELODERMA HORRIDUM VENOM, PICROTOXIN, AMBER, HELLEBORUS NIGER ROOT
Label structure9 sections

Indications and uses

Temporarily alleviates symptoms of concussion or trauma. *These “uses” have not been evaluated by the Food and Drug Administration.

Dosage and administration

Adults and Children 12 years of age and older: Take 1 full eyedropper twice a day to help alleviate symptoms of a hormone imbalance. Under 12 years of age: Consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Absinthium 6X HPUS, 30C HPUS, Causticum 5X HPUS, 30C HPUS, Helleborus Niger 30C HPUS, 200C HPUS, Heloderma 12X HPUS, 15X HPUS, 30C HPUS, 200C HPUS, Picrotoxinum 16X HPUS, 30C HPUS, Ranunculus Glacialis 10X HPUS, 30C HPUS, Succinum 30C HPUS, Theridion 10X HPUS, 30C HPUS, 200C HPUS.

PURPOSE:

OTC - PURPOSE SECTION

Absinthium – For Minor Relief of Nervousness, Causticum – For Minor Relief of Dizziness, Helleborus Niger – For Minor Relief of Headache, Heloderma – For Minor Relief of Headache, Picrotoxinum – For Minor Relief of Stomach Upset, Ranunculus Glacialis – For Minor Relief of Headache, Succinum – For Minor Relief of Dizziness, Theridion – For Minor Relief of Dizziness

USES:

INDICATIONS & USAGE SECTION

Temporarily alleviates symptoms of concussion or trauma.
*These “uses” have not been evaluated by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if: Symptoms persist for more than 7 days or worsen

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or a poison Control Center immediately.

Do not use if seal is broken or missing. 

This Product does not contain sugar, starch, preservatives, artificial flavors or additives, and no wheat, gluten, soy, or milk derivatives.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a medical professional or a poison Control Center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years of age and older: Take 1 full eyedropper twice a day to help alleviate symptoms of a hormone imbalance.
Under 12 years of age: Consult a physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% organic ethanol, purified water

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

Call weekdays 9am-5pm (918)791-1727

**C, K, CK, and X are homeopathic dilutions: See WWW.hpus.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 75053-0005-1

Nu cleic

Cerebellutem

Temperare Regulation Series

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

CerebellutemCerebellutem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75053-0005-1Cerebellutem118 mL in 1 BOTTLE, DROPPERLIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75053-0005CEREBELLUTEM (CAUSTICUM, ABSINTHIUM, RANUNCULUS GLACIALIS, THERIDION, HELODERMA, PICROTOXINUM, SUCCINUM, HELLEBORUS NIGER) LIQUID [NUCLEIC PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20250410_8212dd94-c963-4bcd-9fd6-fa25f51ebe55.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75053-000575053-0005-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAUSTICUMDD5FO1WKFUACTIB
WORMWOODF84709P2XVACTIB
RANUNCULUS GLACIALIS WHOLE14BZI1Z096ACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
HELODERMA HORRIDUM VENOMO9M1UQ4YIOACTIB
PICROTOXINZLT174DL7UACTIB
AMBER70J9Z0J26PACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
CerebellutemCAUSTICUM, ABSINTHIUM, RANUNCULUS GLACIALIS, THERIDION, HELODERMA, PICROTOXINUM, SUCCINUM, HELLEBORUS NIGERNucleic Products, LLC8212dd94-c963-4bcd-9fd6-fa25f51ebe552025-04-08WarningsExact identifier
ndc (package): 75053-0005-1
ndc (product): 75053-0005
ndc11 (package): 75053000501
spl id: 09e6e479-067c-43ec-8ab6-0df01a680ceb
spl set id: 8212dd94-c963-4bcd-9fd6-fa25f51ebe55

Reported adverse events (FAERS/openFDA)#

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