Home NDC 55714-4749-1 Menstrual - PMS
Product NDC 55714-4749
Requested package NDC 55714-4749-1
11-digit product format 557144749
Labeler code 55714
Product ID 55714-4749_b5ab03e7-dae4-7b87-e053-2995a90a42fc
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 2019-09-02
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 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-4749 55714-4749-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-4749 55714-4749-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Menstrual - PMS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANGELICA SINENSIS ROOT 15 [hp_X]/mL ARSENIC TRIOXIDE 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL CAULOPHYLLUM THALICTROIDES ROOT 15 [hp_X]/mL BLACK COHOSH 15 [hp_X]/mL CINCHONA OFFICINALIS BARK 15 [hp_X]/mL DIOSCOREA VILLOSA TUBER 15 [hp_X]/mL ESTRONE 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL LACHESIS MUTA VENOM 15 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/mL ACHILLEA MILLEFOLIUM 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL ANEMONE PULSATILLA 15 [hp_X]/mL JUNIPERUS SABINA LEAFY TWIG 15 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM 15 [hp_X]/mL SEPIA OFFICINALIS JUICE 15 [hp_X]/mL CAPSELLA BURSA-PASTORIS 15 [hp_X]/mL VIBURNUM OPULUS BARK 15 [hp_X]/mL GINGER 15 [hp_X]/mL ECHINACEA, UNSPECIFIED 6 [hp_X]/mL VALERIAN 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-4749-1 Menstrual - PMS 30 mL in 1 BOTTLE, GLASS LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-4749 MENSTRUAL - 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.] 2 Current NDC, Legacy NDC, 1 package rows 20201205_99602037-4650-0c3d-e053-2995a90a37b6.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menstrual - 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 Newton Laboratories, Inc. 99602037-4650-0c3d-e053-2995a90a37b6 2020-12-04 Warnings Exact identifier ndc (package): 55714-4749-1 ndc (product): 55714-4749 ndc11 (package): 55714474901
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-4749-1 55714474901 30 mL in 1 BOTTLE, GLASS (55714-4749-1) 30 ml 2019-09-02 0000-00-00 No No Current