FDA.reportPublic FDA data

Natural Progesterone

Product NDC
43857-0084
11-digit product format
438570084
Labeler code
43857
Product ID
43857-0084_d30b761b-1887-41be-b9c2-a83b4c2520c0
Type
HUMAN OTC DRUG
Nonproprietary name
Progesterone
Dosage form
SPRAY
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-07-09
Substance
PROGESTERONE
Active strength
8 [hp_X]/mL
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Natural Progesterone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4G7DS2Q64YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
772629aa-af5e-4493-aaf2-3c75bfd7d8c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0084-1Natural Progesterone30 mL in 1 BOTTLE, SPRAYSPRAY305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64YNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PROGESTERONEACTIVE MOIETY4G7DS2Q64YNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0084NATURAL PROGESTERONE (PROGESTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20211210_772629aa-af5e-4493-aaf2-3c75bfd7d8c2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural ProgesteronePROGESTERONEBioActive Nutritional, Inc.772629aa-af5e-4493-aaf2-3c75bfd7d8c22026-05-05WarningsExact identifier
ndc (product): 43857-0084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0084-14385700840130 mL in 1 BOTTLE, SPRAY (43857-0084-1) 30 ml2017-02-150000-00-00NoNoCurrent