Helleborus comp. A

Product NDC
48951-5135
11-digit product format
489515135
Labeler code
48951
Product ID
48951-5135_4420fb70-8e19-709c-e063-6394a90a1e7a
Type
HUMAN OTC DRUG
Nonproprietary name
Helleborus comp. A
Dosage form
LIQUID
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-03-11
Substance
ANTIMONY; ARSENIC TRIOXIDE; FORMICA RUFA; HELLEBORUS NIGER ROOT; JUGLANS REGIA LEAF; LEAD MONOSILICATE; PHOSPHORUS; POTASSIUM PHOSPHATE, MONOBASIC; SILVER; TIN
Active strength
6; 17; 6; 3; 7; 20; 12; 6; 8; 12 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Helleborus comp. A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIN6 [hp_X]/mL
PHOSPHORUS17 [hp_X]/mL
ARSENIC TRIOXIDE6 [hp_X]/mL
LEAD MONOSILICATE3 [hp_X]/mL
SILVER7 [hp_X]/mL
FORMICA RUFA20 [hp_X]/mL
ANTIMONY12 [hp_X]/mL
HELLEBORUS NIGER ROOT6 [hp_X]/mL
POTASSIUM PHOSPHATE, MONOBASIC8 [hp_X]/mL
JUGLANS REGIA LEAF12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387GMG9FH5Internal UNII lookup
27YLU75U4WInternal UNII lookup
S7V92P67HOInternal UNII lookup
TLE92T7F1JInternal UNII lookup
3M4G523W1GInternal UNII lookup
55H0W83JO5Internal UNII lookup
9IT35J3UV3Internal UNII lookup
608DGJ6815Internal UNII lookup
4J9FJ0HL51Internal UNII lookup
85HKB87105Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
150e57ad-3ed7-5cc9-e063-6394a90a25feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct 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
48951-5135-1Helleborus comp. A1 mL in 1 AMPULELIQUID13
48951-5135-1Helleborus comp. A10 in 1 BOXLIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5135HELLEBORUS COMP. A LIQUID [URIEL PHARMACY INC.]2Current NDC, 2 package rows20241219_150e57ad-3ed7-5cc9-e063-6394a90a25fe.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
Helleborus comp. AHELLEBORUS COMP. AUriel Pharmacy Inc.150e57ad-3ed7-5cc9-e063-6394a90a25fe2025-11-21WarningsExact identifier
ndc (product): 48951-5135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48951-5135-14895151350110 AMPULE in 1 BOX (48951-5135-1) / 1 mL in 1 AMPULE10 ampule2021-03-11NoNoCurrent