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Approved
Approval ID

9080fb32-8aa7-4769-adb3-03c73743d6e3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Apotheca Company

DUNS: 844330915

Products 1

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

Lycopodium clavatum, Phytolacca decandra, Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Pulsatilla, Kali bichromicum, Ammonium carbonicum, Fucus vesiculosus,

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57520-0228
Product Classification
G
Generic Name
Lycopodium clavatum, Phytolacca decandra, Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Pulsatilla, Kali bichromicum, Ammonium carbonicum, Fucus vesiculosus,
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (24)

LYCOPODIUM CLAVATUM SPOREActive
Quantity: 3 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 3 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB
AMMONIUM BROMIDEActive
Quantity: 6 [hp_X] in 1 mL
Code: R0JB3224WS
Classification: ACTIB
TSUGA CANADENSIS BARKActive
Quantity: 6 [hp_X] in 1 mL
Code: R53V5F950S
Classification: ACTIB
AMMONIUM CHLORIDEActive
Quantity: 200 [hp_X] in 1 mL
Code: 01Q9PC255D
Classification: ACTIM
PULSATILLA VULGARIS WHOLEActive
Quantity: 30 [hp_X] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
POTASSIUM DICHROMATEActive
Quantity: 200 [hp_X] in 1 mL
Code: T4423S18FM
Classification: ACTIB
AMMONIUM CARBONATEActive
Quantity: 6 [hp_X] in 1 mL
Code: NJ5VT0FKLJ
Classification: ACTIB
FUCUS VESICULOSUSActive
Quantity: 200 [hp_X] in 1 mL
Code: 535G2ABX9M
Classification: ACTIB
CAPSICUMActive
Quantity: 200 [hp_X] in 1 mL
Code: 00UK7646FG
Classification: ACTIB
SILVER NITRATEActive
Quantity: 30 [hp_X] in 1 mL
Code: 95IT3W8JZE
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: ETJ7Z6XBU4
Classification: ACTIB
BOS TAURUS ADRENAL GLANDActive
Quantity: 200 [hp_C] in 1 mL
Code: M2776SWB29
Classification: ACTIB
CALCIUM ARSENATEActive
Quantity: 200 [hp_X] in 1 mL
Code: 95OX15I8ZU
Classification: ACTIB
IRONActive
Quantity: 200 [hp_X] in 1 mL
Code: E1UOL152H7
Classification: ACTIB
ANTIMONY TRISULFIDEActive
Quantity: 4 [hp_C] in 1 mL
Code: F79059A38U
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 1 [hp_Q] in 1 mL
Code: 2E32821G6I
Classification: ACTIB
GRAPHITEActive
Quantity: 1 [hp_Q] in 1 mL
Code: 4QQN74LH4O
Classification: ACTIB
POTASSIUM CARBONATEActive
Quantity: 200 [hp_X] in 1 mL
Code: BQN1B9B9HA
Classification: ACTIB
SEMECARPUS ANACARDIUM JUICEActive
Quantity: 4 [hp_C] in 1 mL
Code: Y0F0BU8RDU
Classification: ACTIB
IODINEActive
Quantity: 4 [hp_C] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
THYROIDActive
Quantity: 5 [hp_C] in 1 mL
Code: 6RV024OAUQ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

Dr Theresa Dale's

NDC: 57520-0228-1

HOMEOPATHIC

SLIM

1 fl. oz. (30 ml)

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2010

INDICATIONS: Food Cravings, great appetite, regurgitation of food, nausea, eating releives discomfort, constant belching, bloating, sluggish, overweight.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2010

ACTIVE INGREDIENTS: Lycopodium clavatum 2X, 3X, Phytolacca decandra 3X, Abies canadensis 3X, 6X, Ammonium bromatum 3X, 6X, Ammonium muriaticum 3X, 6X, 12X, 30X, 200X, Pulsatilla 3X, 6X, 30X, Kali bichromicum 3X, 30X, 200X, Ammonium carbonicum 6X, Fucus vesiculosus 6X, 12X, 30X, 60X, 100X, 200X, Capsicum annuum 6X, 12X. 30X, 200X, Argentum nitricum 6X, 30X, Silicea 8X, Glandula suprarenalis bovinum 8X, 30X, 200C, Calcarea arsenicica 12X, 30X, 200X, Ferrum metallicum 12X, 30X, 200X, Antimonium crudum 12X, 30X, 200X, 4C, Calcarea carbonica 12X, 30X, 200X, LM1, Graphites 12X, 30X, 200X, LM1, Kali carbonicum 30X, 60X, 200X, Anacardium orientale 4C, Iodium 4C, Thyroidinum 5C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2010

INDICATIONS: Food Cravings, great appetite, regurgitation of food, nausea, eating relieves discomfort, constant belching, bloating, sluggish, overweight.

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2010

WARNINGS: If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2010

DIRECTIONS: 5 drops, 2 to 3 times per day. Take for 5 days, stop for 2 days, then repeat until you see symptoms abate. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2010

INACTIVE INGREDIENTS: Demineralized water, 25% Alcohol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/1/2010

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2010

MFG FOR:

Theresa Dale, N.D.

1237 S Victoria Ave.

Oxnard, CA 93035

1-866-962-6484

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