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Household Dust and Mold Mix

DRUG FACTS:

Approved
Approval ID

39ce30c9-427c-4e6a-a918-d5478e38b609

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Nutritional Specialties, Inc.

DUNS: 032744609

Products 1

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

Glandula Suprarenalis (Bovine), Hepar (Bovine), Histaminum Hydrochloricum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Dust, Mucor Racemosus, Torula Cerevisiae, House Dust Mite, Adrenocorticotrophin, Rhizopus Nigricans

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83027-0123
Product Classification
G
Generic Name
Glandula Suprarenalis (Bovine), Hepar (Bovine), Histaminum Hydrochloricum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Dust, Mucor Racemosus, Torula Cerevisiae, House Dust Mite, Adrenocorticotrophin, Rhizopus Nigricans
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (15)

BOS TAURUS ADRENAL GLANDActive
Quantity: 6 [hp_X] in 1 mL
Code: M2776SWB29
Classification: ACTIB
BEEF LIVERActive
Quantity: 6 [hp_X] in 1 mL
Code: W8N8R55022
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 3POA0Q644U
Classification: ACTIB
SACCHAROMYCES CEREVISIAEActive
Quantity: 16 [hp_X] in 1 mL
Code: 978D8U419H
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 12 [hp_C] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
CORTICOTROPINActive
Quantity: 15 [hp_C] in 1 mL
Code: K0U68Q2TXA
Classification: ACTIB
RHIZOPUS STOLONIFERActive
Quantity: 15 [hp_C] in 1 mL
Code: FEE198DK4Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALTERNARIA ALTERNATAActive
Quantity: 16 [hp_X] in 1 mL
Code: 52B29REC7H
Classification: ACTIB
ASPERGILLUS NIGER VAR. NIGERActive
Quantity: 16 [hp_X] in 1 mL
Code: 9IOA40ANG6
Classification: ACTIB
CANDIDA ALBICANSActive
Quantity: 16 [hp_X] in 1 mL
Code: 4D7G21HDBC
Classification: ACTIB
CANDIDA PARAPSILOSISActive
Quantity: 16 [hp_X] in 1 mL
Code: 0KZ676D44N
Classification: ACTIB
HOUSE DUSTActive
Quantity: 16 [hp_X] in 1 mL
Code: EYO007VX98
Classification: ACTIB
MUCOR RACEMOSUSActive
Quantity: 16 [hp_X] in 1 mL
Code: 17RH99LQ7G
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/24/2023

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0123-1

HOUSEHOLD

DUST & MOLD MIX

2 FL. OZ (60 ml)

HOUSEHOLD  DUST & MOLD MIX

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2023

INDICATIONS:

Provides factors that mitigate hypersensitivity to household dusts, molds and mites.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/24/2023

ACTIVE INGREDIENTS:

Glandula Suprarenalis 6X, 12X, Hepar (Liver) 6X, 12X, Histaminum Hydrochloricum 12X, Alternaria Tenuis Nees 16X, 60X, 100X, Aspergillus Niger 16X, 60X, 100X, Candida Albicans 16X, 60X, 100X, Candida Parapsilosis 16X, 60X, 100, Dust 16X, 60X, 100, Mucor Racemosus 16X, 60X, 100, Torula Cerevisiae 16X, 60X, 100X, House Dust Mite 12C, 30C, Adrenocorticotrophin 15C, 30C, Rhizopus Nigricans 15C, 30C, 100C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/24/2023

PURPOSE:

Provides factors that mitigate hypersensitivity to household dusts, molds and mites.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/24/2023

WARNINGS:

Professional Use Only

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

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/24/2023

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/24/2023

DIRECTIONS:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/24/2023

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/24/2023

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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Household Dust and Mold Mix - FDA Drug Approval Details