Menopause

Product NDC
55714-4800
Requested package NDC
55714-4800-1
11-digit product format
557144800
Labeler code
55714
Product ID
55714-4800_b5aac7bb-52f7-7f8e-e053-2a95a90a1ae6
Type
HUMAN OTC DRUG
Nonproprietary name
Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
ANEMONE PULSATILLA; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE FRUIT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG; VALERIAN
Active strength
15; 15; 20; 15; 15; 15; 15; 15; 15; 15; 11; 15; 15; 35; 15; 15; 15; 15; 15; 15; 15; 15; 20; 15; 11 [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; [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-480055714-4800-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-480055714-4800-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]/mL
STRYCHNOS IGNATII SEED15 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG20 [hp_X]/mL
NITROGLYCERIN15 [hp_X]/mL
CHAMAELIRIUM LUTEUM ROOT15 [hp_X]/mL
POTASSIUM CARBONATE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
NAJA NAJA VENOM15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
ANEMONE PULSATILLA11 [hp_X]/mL
SALIX NIGRA BARK15 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT15 [hp_X]/mL
SEPIA OFFICINALIS JUICE35 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
VALERIAN15 [hp_X]/mL
MICRURUS CORALLINUS VENOM15 [hp_X]/mL
CHASTE TREE FRUIT15 [hp_X]/mL
ANGELICA SINENSIS ROOT15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
LYTTA VESICATORIA15 [hp_X]/mL
CAULOPHYLLUM THALICTROIDES ROOT20 [hp_X]/mL
BLACK COHOSH15 [hp_X]/mL
CINCHONA OFFICINALIS BARK11 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YHA2XLJ956Internal UNII lookup
1NM3M2487KInternal UNII lookup
RQ2CFA7WWJInternal UNII lookup
G59M7S0WS3Internal UNII lookup
DQV54Y5H3UInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
VSW71SS07IInternal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
QU52J3A5B3Internal UNII lookup
N9288CD508Internal UNII lookup
QDL83WN8C2Internal UNII lookup
4N9P6CC1DXInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
V0S6H36980Internal UNII lookup
433OSF3U8AInternal UNII lookup
B66F4574UGInternal UNII lookup
S7V92P67HOInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
995f6b76-b98e-0d32-e053-2995a90a14feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4800-1Menopause30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4800MENOPAUSE (ELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201205_995f6b76-b98e-0d32-e053-2995a90a14fe.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
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.995f6b76-b98e-0d32-e053-2995a90a14fe2020-12-04WarningsExact identifier
ndc (package): 55714-4800-1
ndc (product): 55714-4800
ndc11 (package): 55714480001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4800-15571448000130 mL in 1 BOTTLE, GLASS (55714-4800-1) 30 ml2019-09-020000-00-00NoNoCurrent