Heilen

Product NDC
70719-0003
11-digit product format
707190003
Labeler code
70719
Product ID
70719-0003_a5b8f01b-807d-4afe-9392-abd145e524e3
Type
HUMAN OTC DRUG
Nonproprietary name
Galium Aparine, Agnus Castus, Apis Mellifica, Capsicum Annuum, Chelidonium Majus, Taraxacum Officinale, Urtica Dioica, Xanthoxylum Fraxineum, Fucus Vesiculosus, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum, Sarsaparilla (smilax Regelii), Ubidecarenonum, Calcarea Carbonica, Graphites, Lycopodium Clavatum, Anacardium Orientale, Colchicum Autumnale, Nux Vomica, Phytolacca Decandra, Pulsatilla (Pratensis), Histaminum Hydrochloricum
Dosage form
LIQUID
Route
ORAL
Labeler
Heilen
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-01-21
Marketing end
2027-02-04
Substance
APIS MELLIFERA; CAPSICUM; CHASTE TREE FRUIT; CHELIDONIUM MAJUS WHOLE; COLCHICUM AUTUMNALE BULB; DIBASIC POTASSIUM PHOSPHATE; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA PRATENSIS WHOLE; SEMECARPUS ANACARDIUM JUICE; SMILAX ORNATA ROOT; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; UBIDECARENONE; URTICA DIOICA WHOLE; ZANTHOXYLUM AMERICANUM BARK
Active strength
6; 6; 6; 6; 30; 12; 6; 3; 12; 200; 12; 12; 12; 30; 30; 30; 12; 12; 30; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heilen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALIUM APARINE WHOLE6 [hp_X]/mL
CHASTE TREE FRUIT6 [hp_X]/mL
APIS MELLIFERA6 [hp_X]/mL
CAPSICUM6 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE30 [hp_C]/mL
TARAXACUM OFFICINALE12 [hp_X]/mL
URTICA DIOICA WHOLE6 [hp_X]/mL
ZANTHOXYLUM AMERICANUM BARK3 [hp_X]/mL
FUCUS VESICULOSUS12 [hp_X]/mL
DIBASIC POTASSIUM PHOSPHATE200 [hp_C]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]/mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]/mL
SMILAX ORNATA ROOT12 [hp_X]/mL
UBIDECARENONE30 [hp_C]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]/mL
GRAPHITE30 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
SEMECARPUS ANACARDIUM JUICE12 [hp_X]/mL
COLCHICUM AUTUMNALE BULB30 [hp_C]/mL
STRYCHNOS NUX-VOMICA SEED6 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE6 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 23 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z4B6561488Internal UNII lookup
433OSF3U8AInternal UNII lookup
7S82P3R43ZInternal UNII lookup
00UK7646FGInternal UNII lookup
7E889U5RNNInternal UNII lookup
39981FM375Internal UNII lookup
710FLW4U46Internal UNII lookup
A4KL1HMZ7TInternal UNII lookup
535G2ABX9MInternal UNII lookup
CI71S98N1ZInternal UNII lookup
HF539G9L3QInternal UNII lookup
70WT22SF4BInternal UNII lookup
2H1576D5WGInternal UNII lookup
EJ27X76M46Internal UNII lookup
2E32821G6IInternal UNII lookup
4QQN74LH4OInternal UNII lookup
C88X29Y479Internal UNII lookup
Y0F0BU8RDUInternal UNII lookup
993QHL78E6Internal UNII lookup
269XH13919Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef3f66f9-47bc-4fce-8950-ed2319bc30d6Available 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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70719-0003-1Heilen30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70719-0003HEILEN (GALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUM) LIQUID [HEILEN]1Current NDC, Legacy NDC, 1 package rows20220123_ef3f66f9-47bc-4fce-8950-ed2319bc30d6.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
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
ndc (product): 70719-0003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70719-0003-17071900030130 mL in 1 BOTTLE, DROPPER (70719-0003-1) 30 ml2022-01-212027-02-04NoNoCurrent