Menstrual - PMS

Product NDC
55714-2481
11-digit product format
557142481
Labeler code
55714
Product ID
55714-2481_2d94fdb8-6829-3390-e063-6294a90a63b0
Type
HUMAN OTC DRUG
Nonproprietary name
Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ACHILLEA MILLEFOLIUM; ANEMONE PULSATILLA; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAPSELLA BURSA-PASTORIS; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; GINGER; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VIBURNUM OPULUS BARK
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15 [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], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACHILLEA MILLEFOLIUM15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
ANGELICA SINENSIS ROOT15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BLACK COHOSH15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CAPSELLA BURSA-PASTORIS15 [hp_X]/mL
CAULOPHYLLUM THALICTROIDES ROOT15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM15 [hp_X]/mL
DIOSCOREA VILLOSA TUBER15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
ESTRONE15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
GINGER15 [hp_X]/mL
JUNIPERUS SABINA LEAFY TWIG15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LILIUM LANCIFOLIUM WHOLE FLOWERING15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
VALERIAN6 [hp_X]/mL
VIBURNUM OPULUS BARK15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FXJ6SW4PK, I76KB35JEV, B66F4574UG, S7V92P67HO, K73E24S6X9, T7J046YI2B, W0X9457M59, JTJ6HH6YEH, S003A158SB, 01G9XEA93N, IWY3IWX2G8, 4N9P6CC1DX, 2DI9HA706A, 639KR60Q1Q, C5529G5JPQ, Z5BEX9K2G1, VSW71SS07I, X67Z2963PI, C88X29Y479, QDL83WN8C2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2481-1Menstrual - PMS30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2481MENSTRUAL - PMS (ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9c496655-8a6a-47e2-e053-2a95a90a7f01.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2481-15571424810130 mL in 1 BOTTLE, GLASS (55714-2481-1) 30 ml2019-01-010000-00-00NoNoCurrent