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
ANTIMONY6 [hp_X]/mL
ARSENIC TRIOXIDE17 [hp_X]/mL
FORMICA RUFA6 [hp_X]/mL
HELLEBORUS NIGER ROOT3 [hp_X]/mL
JUGLANS REGIA LEAF7 [hp_X]/mL
LEAD MONOSILICATE20 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
POTASSIUM PHOSPHATE, MONOBASIC6 [hp_X]/mL
SILVER8 [hp_X]/mL
TIN12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IT35J3UV3, S7V92P67HO, 55H0W83JO5, 608DGJ6815, 85HKB87105, TLE92T7F1J, 27YLU75U4W, 4J9FJ0HL51, 3M4G523W1G, 387GMG9FH5

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

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 ampule2021-03-11NoNoHistorical