Home NDC 53499-1391-1 ALPHA SH
Product NDC 53499-1391
Requested package NDC 53499-1391-1
11-digit product format 534991391
Labeler code 53499
Product ID 53499-1391_99987865-e648-4746-ab77-ff24708d2a8e
Type HUMAN OTC DRUG
Nonproprietary name SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS
Dosage form TABLET
Route SUBLINGUAL
Labeler Schwabe North America, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2011-08-18
Marketing end 2027-01-31
Substance GOLDENSEAL; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE
Active strength 6; 3; 6; 6; 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 North America, Inc. 94de9ce3-6ee9-4322-bda2-0b4391f09d87 2022-03-22 Warnings Exact identifier ndc (package): 53499-1391-1 ndc (product): 53499-1391 ndc11 (package): 53499139101
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 3 [hp_X]/1 SILICON DIOXIDE 6 [hp_X]/1 POTASSIUM CHLORIDE 6 [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 53499-1391-1 ALPHA SH 10 in 1 BLISTER PACK TABLET 10 10 53499-1391-1 ALPHA SH 4 in 1 BOX TABLET 4 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GOLDENSEAL ACTIVE INGREDIENT ZW3Z11D0JV ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 PULSATILLA VULGARIS ACTIVE INGREDIENT I76KB35JEV ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 SANGUINARIA CANADENSIS ROOT ACTIVE INGREDIENT N9288CD508 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 SILICON DIOXIDE ACTIVE INGREDIENT ETJ7Z6XBU4 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 GOLDENSEAL ACTIVE MOIETY ZW3Z11D0JV ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 POTASSIUM CATION ACTIVE MOIETY 295O53K152 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 PULSATILLA VULGARIS ACTIVE MOIETY I76KB35JEV ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 SANGUINARIA CANADENSIS ROOT ACTIVE MOIETY N9288CD508 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 SILICON DIOXIDE ACTIVE MOIETY ETJ7Z6XBU4 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [NATURES WAY HOLDING CO.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-1391 ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [SCHWABE NORTH AMERICA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20220323_94de9ce3-6ee9-4322-bda2-0b4391f09d87.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53499-1391-1 53499139101 4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACK 4 blister pack 2011-08-18 2027-01-31 No No Current