FDA Product

SPEARMINT

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

SPEARMINT

FDA Product Code

54575-459

Regulatory Information

NDC Product Code

54575-459

Application Number

BLA102192

Marketing Category

C73585

Effective Date

March 15, 2011

Territorial Authority

USA

FDA Title

Allergenic Extracts

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerAllergy Laboratories, Inc.

DUNS Number

007191810

Active Ingredients

SODIUM BICARBONATE

Quantity: 0.091 g in 100 mL

Code: 8MDF5V39QO

Class Code: IACT

GLYCERIN

Quantity: 50 mL in 100 mL

Code: PDC6A3C0OX

Class Code: IACT

SODIUM CHLORIDE

Quantity: 0.166 g in 100 mL

Code: 451W47IQ8X

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Quantity: 1 g in 20 mL

Code: J7I2T6IV1N

Class Code: ACTIB

Active Moieties

SPEARMINT

Code: J7I2T6IV1N

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