Menopause

Product NDC
55714-2480
Requested package NDC
55714-2480-1
11-digit product format
557142480
Labeler code
55714
Product ID
55714-2480_2d92ad4f-29f8-dfe1-e063-6294a90a4221
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
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
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
10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 6; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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 · 3 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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-248055714-2480-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-248055714-2480-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-248055714-2480-1UExcluded 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
MICRURUS CORALLINUS VENOM10 [hp_X]/g
CHASTE TREE FRUIT10 [hp_X]/g
ANGELICA SINENSIS ROOT15 [hp_X]/g
ARSENIC TRIOXIDE10 [hp_X]/g
BRYONIA ALBA ROOT10 [hp_X]/g
LYTTA VESICATORIA10 [hp_X]/g
CAULOPHYLLUM THALICTROIDES ROOT10 [hp_X]/g
BLACK COHOSH10 [hp_X]/g
CINCHONA OFFICINALIS BARK10 [hp_X]/g
CROTALUS HORRIDUS HORRIDUS VENOM10 [hp_X]/g
TURNERA DIFFUSA LEAFY TWIG6 [hp_X]/g
NITROGLYCERIN10 [hp_X]/g
CHAMAELIRIUM LUTEUM ROOT10 [hp_X]/g
STRYCHNOS IGNATII SEED30 [hp_X]/g
POTASSIUM CARBONATE10 [hp_X]/g
LACHESIS MUTA VENOM10 [hp_X]/g
NAJA NAJA VENOM10 [hp_X]/g
STRYCHNOS NUX-VOMICA SEED10 [hp_X]/g
PHOSPHORUS10 [hp_X]/g
VALERIAN10 [hp_X]/g
ANEMONE PULSATILLA10 [hp_X]/g
SALIX NIGRA BARK10 [hp_X]/g
SANGUINARIA CANADENSIS ROOT15 [hp_X]/g
SEPIA OFFICINALIS JUICE10 [hp_X]/g
ECHINACEA, UNSPECIFIED6 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V0S6H36980Internal UNII lookup
433OSF3U8AInternal UNII lookup
B66F4574UGInternal UNII lookup
S7V92P67HOInternal UNII lookup
T7J046YI2BInternal UNII lookup
3Q034RO3BTInternal UNII lookup
JTJ6HH6YEHInternal UNII lookup
K73E24S6X9Internal UNII lookup
S003A158SBInternal UNII lookup
YHA2XLJ956Internal UNII lookup
RQ2CFA7WWJInternal UNII lookup
G59M7S0WS3Internal UNII lookup
DQV54Y5H3UInternal UNII lookup
1NM3M2487KInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
VSW71SS07IInternal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c4872fd-bfe5-2472-e053-2995a90a361fAvailable 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
55714-2480-1Menopause28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2480MENOPAUSE (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) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9c4872fd-bfe5-2472-e053-2995a90a361f.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.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
ndc (package): 55714-2480-1
ndc (product): 55714-2480
ndc11 (package): 55714248001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2480-15571424800128 g in 1 BOTTLE, GLASS (55714-2480-1) 28 g2019-01-010000-00-00NoNoCurrent