Home NDC 68466-4191 ALPHA SH
Product NDC 68466-4191
11-digit product format 684664191
Labeler code 68466
Product ID 68466-4191_32449721-13e2-4194-b1c1-8e1dc3b33de4
Type HUMAN OTC DRUG
Nonproprietary name SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS
Dosage form TABLET
Route SUBLINGUAL
Labeler Schwabe Mexico, S.A. de C.V.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-10-16
Marketing end 2027-01-31
Substance SANGUINARIA CANADENSIS ROOT; GOLDENSEAL; SILICON DIOXIDE; POTASSIUM CHLORIDE; PULSATILLA VULGARIS
Active strength 6; 6; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
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 ALPHA SH Active Ingredients# Ingredient, Strength table Ingredient Strength SANGUINARIA CANADENSIS ROOT 6 [hp_X]/1 GOLDENSEAL 6 [hp_X]/1 SILICON DIOXIDE 6 [hp_X]/1 POTASSIUM CHLORIDE 3 [hp_X]/1 PULSATILLA VULGARIS 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68466-4191-1 ALPHA SH 10 in 1 BLISTER PACK TABLET 10 3 68466-4191-1 ALPHA SH 4 in 1 BOX TABLET 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68466-4191 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [SCHWABE MEXICO, S.A. DE C.V.] 3 Current NDC, Legacy NDC, 2 package rows 20220323_3e2e5f52-db54-4635-83a8-a67a683c093c.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS Schwabe Mexico, S.A. de C.V. 3e2e5f52-db54-4635-83a8-a67a683c093c 2022-03-22 Warnings Exact identifier ndc (product): 68466-4191
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68466-4191-1 68466419101 4 BLISTER PACK in 1 BOX (68466-4191-1) / 10 TABLET in 1 BLISTER PACK 4 blister pack 2020-10-16 2027-01-31 No No Current