FDA.reportPublic FDA data

Menopause

Product NDC
43857-0446
Requested package NDC
43857-0446-1
11-digit product format
438570446
Labeler code
43857
Product ID
43857-0446_adaffaed-4e3a-45ab-9eff-e71162133c80
Type
HUMAN OTC DRUG
Nonproprietary name
Angelica Archangelica, Aralia Quinquefolia, Cimicifuga Racemosa, Hydrastis Canadensis, Pulsatilla, Sabina, Sepia, Sulphuricum Acidum, Lachesis Mutus
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-05-18
Substance
AMERICAN GINSENG; ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; GOLDENSEAL; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SULFURIC ACID
Active strength
3; 3; 3; 5; 12; 15; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Menopause
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGELICA ARCHANGELICA ROOT3 [hp_X]/mL
AMERICAN GINSENG3 [hp_X]/mL
BLACK COHOSH3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
JUNIPERUS SABINA LEAFY TWIG15 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SULFURIC ACID12 [hp_X]/mL
LACHESIS MUTA VENOM12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DTN01M69SNInternal UNII lookup
8W75VCV53QInternal UNII lookup
K73E24S6X9Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
I76KB35JEVInternal UNII lookup
Z5BEX9K2G1Internal UNII lookup
QDL83WN8C2Internal UNII lookup
O40UQP6WCFInternal UNII lookup
VSW71SS07IInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03ce1f50-6af5-4640-825f-67fcb25e76e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0446-1Menopause30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0446MENOPAUSE (ANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20170522_03ce1f50-6af5-4640-825f-67fcb25e76e6.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
MenopauseANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.03ce1f50-6af5-4640-825f-67fcb25e76e62025-06-24WarningsExact identifier
ndc (package): 43857-0446-1
ndc (product): 43857-0446
ndc11 (package): 43857044601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0446-14385704460130 mL in 1 BOTTLE, DROPPER (43857-0446-1) 30 ml2017-05-180000-00-00NoNoCurrent