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Shame

DRUG FACTS:

Approved
Approval ID

090e4a23-3e1b-4b0c-a0cc-0172b05f7b64

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Deseret Biologicals, Inc.

DUNS: 940741853

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adrenalinum, Agnus Castus, Aloe, Ambra Grisea, Aurum Muriaticum Natronatum, Baryta Carbonica, Calcarea Iodata, Candida Albicans, Cerebrum Suis, Cinchona Officinalis, Digitalis Purpurea, Hypothalamus Suis, Ignatia Amara, Lac Defloratum, Lycopodium Clavatum, Natrum Muriaticum, Rhus Glabra, Saccharum Officinale, Serotonin (Hydrochloride), Staphysagria, Thuja Occidentalis

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-2276
Product Classification
G
Generic Name
Adrenalinum, Agnus Castus, Aloe, Ambra Grisea, Aurum Muriaticum Natronatum, Baryta Carbonica, Calcarea Iodata, Candida Albicans, Cerebrum Suis, Cinchona Officinalis, Digitalis Purpurea, Hypothalamus Suis, Ignatia Amara, Lac Defloratum, Lycopodium Clavatum, Natrum Muriaticum, Rhus Glabra, Saccharum Officinale, Serotonin (Hydrochloride), Staphysagria, Thuja Occidentalis
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (23)

EPINEPHRINEActive
Quantity: 6 [hp_X] in 1 mL
Code: YKH834O4BH
Classification: ACTIB
CHASTE TREE FRUITActive
Quantity: 12 [hp_X] in 1 mL
Code: 433OSF3U8A
Classification: ACTIB
ALOEActive
Quantity: 8 [hp_X] in 1 mL
Code: V5VD430YW9
Classification: ACTIB
AMBERGRISActive
Quantity: 6 [hp_X] in 1 mL
Code: XTC0D02P6C
Classification: ACTIB
SODIUM TETRACHLOROAURATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 7FT6QUT299
Classification: ACTIB
CALCIUM IODIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 8EKI9QEE2H
Classification: ACTIB
CANDIDA ALBICANSActive
Quantity: 12 [hp_X] in 1 mL
Code: 4D7G21HDBC
Classification: ACTIB
SUS SCROFA CEREBRUMActive
Quantity: 8 [hp_X] in 1 mL
Code: 4GB5DQR532
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 12 [hp_X] in 1 mL
Code: S003A158SB
Classification: ACTIB
DIGITALISActive
Quantity: 12 [hp_X] in 1 mL
Code: F1T8QT9U8B
Classification: ACTIB
SUS SCROFA HYPOTHALAMUSActive
Quantity: 8 [hp_X] in 1 mL
Code: N6R0856Z79
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 12 [hp_X] in 1 mL
Code: 1NM3M2487K
Classification: ACTIB
SKIM MILKActive
Quantity: 6 [hp_X] in 1 mL
Code: 6A001Y4M5A
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 12 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 mL
Code: 451W47IQ8X
Classification: ACTIB
SUCROSEActive
Quantity: 30 [hp_X] in 1 mL
Code: C151H8M554
Classification: ACTIB
DELPHINIUM STAPHISAGRIA SEEDActive
Quantity: 12 [hp_X] in 1 mL
Code: 00543AP1JV
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BARIUM CARBONATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 6P669D8HQ8
Classification: ACTIB
SEROTONIN HYDROCHLORIDEActive
Quantity: 6 [hp_X] in 1 mL
Code: GKN429M9VS
Classification: ACTIB
RHUS GLABRA TOPActive
Quantity: 12 [hp_X] in 1 mL
Code: RHH784E0K6
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

PACKAGE LABEL DISPLAY:

Shame

Homeopathic

NDC 43742-2276-1

1 FL OZ (30 ml)

Shame

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

USES:

• For the temporary relief of symptoms including:
• self-consciousness • shame • embarrassment • fear of strangers • lack of confidence • worthlessness

•guilt • avoiding attention • hiding • excessive apologizing • fear of failure • poor eye contact

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

ACTIVE INGREDIENTS:

Adrenalinum 6X, 12X, 30X, Agnus Castus 12X, Aloe 8X, Ambra Grisea 6X, 12X, 30X, Aurum Muriaticum Natronatum 12X, Baryta Carbonica 12X, Calcarea Iodata 12X, Candida Albicans 12X, 18X, 30X, Cerebrum Suis 8X, Cinchona Officinalis 12X, Digitalis Purpurea 12X, Hypothalamus Suis 8X, Ignatia Amara 12X, Lac Defloratum 6X, 12X, 30X, Lycopodium Clavatum 12X, Natrum Muriaticum 6X, Rhus Glabra 12X, Saccharum Officinale 30X, Serotonin (Hydrochloride) 6X, 12X, 30X, Staphysagria 12X, Thuja Occidentalis 6X, 12X, 30X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

PURPOSE:

Adrenalinum – Self-Consciousness, Agnus Castus - Shame, Aloe - Embarrassment, Ambra Grisea - Embarrassment, Aurum Muriaticum Natronatum – Lack of Confidence, Baryta Carbonica - Worthlessness, Calcarea Iodata – Fear of Failure, Candida Albicans - Guilt, Cerebrum Suis – Avoiding Attention, Cinchona Officinalis – Excessive Apologizing, Digitalis Purpurea - Shame, Hypothalamus Suis – Lack of Confidence, Ignatia Amara – Fear of Strangers, Lac Defloratum - Hiding, Lycopodium Clavatum – Fear of Failure, Natrum Muriaticum – Avoiding Attention, Rhus Glabra – Poor Eye Contact, Saccharum Officinale - Worthlessness, Serotonin (Hydrochloride) - Guilt, Staphysagria - Embarrassment, Thuja Occidentalis - Embarrassment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

WARNINGS:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, contact a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/12/2025

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.co

800-827-8204

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Shame - FDA Drug Approval Details