MedPath

STRE HOMO

DRUG FACTS:

Approved
Approval ID

6b323d56-19c5-44da-9a84-ca5a3ad5323d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 9, 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.

DNA, Enterococcus Faecalis, Streptococcus Agalactiae, Streptococcus Bovis , Streptococcus Dysgalactiae, Streptococcus Mutans, Streptococcus Oralis, Streptococcus Pneumoniae, Streptococcus Uberis, Streptococcus Viridans

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43742-2262
Product Classification
G
Generic Name
DNA, Enterococcus Faecalis, Streptococcus Agalactiae, Streptococcus Bovis , Streptococcus Dysgalactiae, Streptococcus Mutans, Streptococcus Oralis, Streptococcus Pneumoniae, Streptococcus Uberis, Streptococcus Viridans
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification

INGREDIENTS (12)

STREPTOCOCCUS AGALACTIAEActive
Quantity: 15 [hp_X] in 1 mL
Code: 2B3763S671
Classification: ACTIB
STREPTOCOCCUS EQUINUSActive
Quantity: 15 [hp_X] in 1 mL
Code: R2P4NKP3ZK
Classification: ACTIB
STREPTOCOCCUS DYSGALACTIAEActive
Quantity: 15 [hp_X] in 1 mL
Code: LN0SH02Y5M
Classification: ACTIB
STREPTOCOCCUS ORALISActive
Quantity: 15 [hp_X] in 1 mL
Code: A41674465B
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAEActive
Quantity: 15 [hp_X] in 1 mL
Code: BT6U234YR2
Classification: ACTIB
STREPTOCOCCUS UBERISActive
Quantity: 15 [hp_X] in 1 mL
Code: O84V4ZK4BX
Classification: ACTIB
STREPTOCOCCUS VIRIDANS GROUPActive
Quantity: 15 [hp_X] in 1 mL
Code: NNV2379HKR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HERRING SPERM DNAActive
Quantity: 15 [hp_X] in 1 mL
Code: 51FI676N6F
Classification: ACTIB
ENTEROCOCCUS FAECALISActive
Quantity: 15 [hp_X] in 1 mL
Code: 15E04LZ9CT
Classification: ACTIB
STREPTOCOCCUS MUTANSActive
Quantity: 15 [hp_X] in 1 mL
Code: 5C7J33MJJ1
Classification: ACTIB

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STRE HOMO - FDA Drug Approval Details