FDA.reportPublic FDA data

TH-101

Product NDC
71018-002
Requested package NDC
71018-002-02
11-digit product format
710180002
Labeler code
71018
Product ID
71018-002_d44c6b5a-0613-71d7-e053-2995a90ac9f7
Type
HUMAN OTC DRUG
Nonproprietary name
Calc carb, Carbo veg, Chelidonium maj, CoQ10, Fucus, Graphites, Homeopathic glycoprotein complex, Hypothalamus, Kali phos, Lycopodium, Mag phos, Nat mur, Nat phos, Nux vom, Ornithogalum, Phytolacca, Pituitarum, Placenta, Sinapis arv flos, Quercus gland sp, Quercus rob
Dosage form
LIQUID
Route
ORAL
Labeler
Temple Health Nutrition, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-05-08
Substance
OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; UBIDECARENONE; FUCUS VESICULOSUS; GRAPHITE; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; ORNITHOGALUM UMBELLATUM; PHYTOLACCA AMERICANA ROOT; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; QUERCUS ROBUR NUT; QUERCUS ROBUR TWIG BARK; SUCROSE; ARGININE; CYSTEINE; LEUCINE; PROLINE; SERINE; THREONINE; VALINE
Active strength
12; 4; 6; 12; 4; 6; 12; 6; 6; 6; 6; 12; 6; 6; 6; 12; 12; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TH-101
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/59mL
ACTIVATED CHARCOAL4 [hp_X]/59mL
CHELIDONIUM MAJUS6 [hp_X]/59mL
UBIDECARENONE12 [hp_X]/59mL
FUCUS VESICULOSUS4 [hp_X]/59mL
GRAPHITE6 [hp_X]/59mL
BOS TAURUS HYPOTHALAMUS12 [hp_X]/59mL
POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]/59mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/59mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]/59mL
SODIUM CHLORIDE6 [hp_X]/59mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]/59mL
STRYCHNOS NUX-VOMICA SEED6 [hp_X]/59mL
ORNITHOGALUM UMBELLATUM6 [hp_X]/59mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/59mL
SUS SCROFA PITUITARY GLAND12 [hp_X]/59mL
SUS SCROFA PLACENTA12 [hp_X]/59mL
SINAPIS ARVENSIS FLOWERING/FRUITING TOP6 [hp_X]/59mL
QUERCUS ROBUR NUT6 [hp_X]/59mL
QUERCUS ROBUR TWIG BARK6 [hp_X]/59mL
SUCROSE8 [hp_X]/59mL
ARGININE8 [hp_X]/59mL
CYSTEINE8 [hp_X]/59mL
LEUCINE8 [hp_X]/59mL
PROLINE8 [hp_X]/59mL
SERINE8 [hp_X]/59mL
THREONINE8 [hp_X]/59mL
VALINE8 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 28 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2E32821G6IInternal UNII lookup
2P3VWU3H10Internal UNII lookup
7E889U5RNNInternal UNII lookup
EJ27X76M46Internal UNII lookup
535G2ABX9MInternal UNII lookup
4QQN74LH4OInternal UNII lookup
S6G2NLH4Y7Internal UNII lookup
CI71S98N1ZInternal UNII lookup
C88X29Y479Internal UNII lookup
HF539G9L3QInternal UNII lookup
451W47IQ8XInternal UNII lookup
70WT22SF4BInternal UNII lookup
269XH13919Internal UNII lookup
9NS3M2Y78SInternal UNII lookup
11E6VI8VEGInternal UNII lookup
L0PFEMQ1DTInternal UNII lookup
C8CV8867O8Internal UNII lookup
WWX61E1ZAKInternal UNII lookup
Q7MU1F4GLYInternal UNII lookup
2JFK226947Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d54bb860-560c-4f8f-9aea-a0b7774cc92bAvailable 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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71018-002-02TH-10159 mL in 1 BOTTLE, DROPPERLIQUID593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71018-002TH-101 (CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB) LIQUID [TEMPLE HEALTH NUTRITION, LLC]3Current NDC, Legacy NDC, 1 package rows20211230_d54bb860-560c-4f8f-9aea-a0b7774cc92b.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
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
ndc (package): 71018-002-02
ndc (product): 71018-002
ndc11 (package): 71018000202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71018-002-027101800020259 mL in 1 BOTTLE, DROPPER (71018-002-02) 59 ml2017-05-080000-00-00NoNoCurrent