FDA.reportPublic FDA data

HFE

Product NDC
62106-0623
11-digit product format
621060623
Labeler code
62106
Product ID
62106-0623_c7c0766c-5fa4-95e0-e053-2995a90ac48f
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mellifica, Belladonna, Caulophyllum thalictroides, Cimicifuga racemosa, Dioscorea villosa, Gelsemium sempervirens, Helonias dioica, Magnesia phosphorica, Oryctolagus cuniculus (Rabbit) Adrenal Gland, Oryctolagus cuniculus (Rabbit) Ovary, Oryctolagus cuniculus (Rabbit) Uterus, Viburnum opulus
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-12-18
Substance
APIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; DIOSCOREA VILLOSA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORYCTOLAGUS CUNICULUS ADRENAL GLAND; ORYCTOLAGUS CUNICULUS OVARY; ORYCTOLAGUS CUNICULUS UTERUS; VIBURNUM OPULUS BARK
Active strength
5; 4; 6; 4; 4; 4; 8; 10; 10; 10; 10; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIOSCOREA VILLOSA ROOT5 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS OVARY4 [hp_X]/30mL
APIS MELLIFERA6 [hp_X]/30mL
ATROPA BELLADONNA4 [hp_X]/30mL
BLACK COHOSH4 [hp_X]/30mL
CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]/30mL
CHAMAELIRIUM LUTEUM ROOT8 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS ADRENAL GLAND10 [hp_X]/30mL
VIBURNUM OPULUS BARK10 [hp_X]/30mL
GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]/30mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS UTERUS2 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IWY3IWX2G8Internal UNII lookup
XA09528U2RInternal UNII lookup
7S82P3R43ZInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
K73E24S6X9Internal UNII lookup
JTJ6HH6YEHInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
QGY289M89QInternal UNII lookup
T1UG6H6805Internal UNII lookup
639KR60Q1QInternal UNII lookup
HF539G9L3QInternal UNII lookup
NQX84Z32G6Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d508fdd-ba8b-07ec-e053-2991aa0a29efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-0623-0HFE30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-0623HFE (APIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUS) LIQUID [SEROYAL USA]3Current NDC, Legacy NDC, 1 package rows20210724_7d508fdd-ba8b-07ec-e053-2991aa0a29ef.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
HFEAPIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUSSeroyal USA7d508fdd-ba8b-07ec-e053-2991aa0a29ef2021-07-22WarningsExact identifier
ndc (product): 62106-0623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62106-0623-06210606230030 mL in 1 BOTTLE, GLASS (62106-0623-0) 30 ml2018-12-180000-00-00NoNoCurrent