FDA.reportPublic FDA data

Menorrhagia

Product NDC
55714-4521
11-digit product format
557144521
Labeler code
55714
Product ID
55714-4521_bafa54f7-58e2-4499-46df-321ada366b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
ALETRIS FARINOSA ROOT; APOCYNUM CANNABINUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CONIUM MACULATUM FLOWERING TOP; CHAMAELIRIUM LUTEUM ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ACHILLEA MILLEFOLIUM; PHOSPHORUS; CLAVICEPS PURPUREA SCLEROTIUM; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM ROOT; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL
Active strength
15 [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
Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Food Additives [CS],Allergens [CS],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4521-12020-01-31C16284748780-19d75b9cf-f734-f424-e053-dadaa90a57ceMenorrhagia
55714-4521-22020-01-31C16284748780-19d75b9cf-f734-f424-e053-dadaa90a57ceMenorrhagia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4521-1Menorrhagia28.35 g in 1 BOTTLE, GLASSPELLET28.351
55714-4521-2Menorrhagia56.7 g in 1 BOTTLE, GLASSPELLET56.71

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Achillea MillefoliumACTIVE INGREDIENT2FXJ6SW4PKMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Aletris Farinosa RootACTIVE INGREDIENTO021JGR97XMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Apis MelliferaACTIVE INGREDIENT7S82P3R43ZMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Apocynum Cannabinum RootACTIVE INGREDIENT2F92409L9ZMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Capsella Bursa-pastorisACTIVE INGREDIENTW0X9457M59MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Chamaelirium Luteum RootACTIVE INGREDIENTDQV54Y5H3UMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SBMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
CinnamonACTIVE INGREDIENT5S29HWU6QBMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Claviceps Purpurea SclerotiumACTIVE INGREDIENT01G9XEA93NMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF371MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
GoldensealACTIVE INGREDIENTZW3Z11D0JVMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJSMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Lilium Lancifolium Whole FloweringACTIVE INGREDIENTX67Z2963PIMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
PhosphorusACTIVE INGREDIENT27YLU75U4WMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Trillium Erectum RootACTIVE INGREDIENTAHW6F0T2X0MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Achillea MillefoliumACTIVE MOIETY2FXJ6SW4PKMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Aletris Farinosa RootACTIVE MOIETYO021JGR97XMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Apis MelliferaACTIVE MOIETY7S82P3R43ZMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Apocynum Cannabinum RootACTIVE MOIETY2F92409L9ZMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Capsella Bursa-pastorisACTIVE MOIETYW0X9457M59MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Chamaelirium Luteum RootACTIVE MOIETYDQV54Y5H3UMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SBMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
CinnamonACTIVE MOIETY5S29HWU6QBMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Claviceps Purpurea SclerotiumACTIVE MOIETY01G9XEA93NMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF371MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
GoldensealACTIVE MOIETYZW3Z11D0JVMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJSMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Lilium Lancifolium Whole FloweringACTIVE MOIETYX67Z2963PIMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
PhosphorusACTIVE MOIETY27YLU75U4WMENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
Trillium Erectum RootACTIVE MOIETYAHW6F0T2X0MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4521MENORRHAGIA (ALETRIS, APOCYNUM, CINCHONA, CINNAMOMUM, CONIUM, HELONIAS DIOICA, LILIUM, MILLEFOLIUM, PHOSPHORUS, SECALE, THLASPI, TRILLIUM PENDULUM, APIS MEL., HAMAMELIS, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20131107_a6598a5b-5714-aae6-80ca-e9284fcb3c66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55714-4521-15571445210128.35 g in 1 BOTTLE, GLASS28.35 gHistorical
55714-4521-25571445210256.7 g in 1 BOTTLE, GLASS56.7 gHistorical