Home › NDC Lookup › Ingredients › Sanguinaria Canadensis Root, Goldenseal,... › 53499-1391-01
ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 6 [hp_X]/1 Tablet, 40-count — NDC 53499-1391-01 package photo

ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 6 [hp_X]/1 Tablet, 40-count

by Schwabe North America, Inc. · 4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACK
NDC 53499-1391-01
🏷️ FDA NDC (as labeled) 53499-1391-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 53499-1391-1
Product NDC 53499-1391
11-digit billing NDC 53499139101
UNII N9288CD508, ZW3Z11D0JV, ETJ7Z6XBU4, 660YQ98I10, I76KB35JEV
UPC 0308078013909
SPL Set ID 94de9ce3-6ee9-4322-bda2-0b4391f09d87
Established class (EPC) Osmotic Laxative; Potassium Salt
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Potassium Compounds
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-18
Marketing end 2027-01-31
Route SUBLINGUAL
Dosage form TABLET
Substance SANGUINARIA CANADENSIS ROOT; GOLDENSEAL; SILICON DIOXIDE; POTASSIUM CHLORIDE; PULSATILLA VULGARIS
Why two NDCs? The FDA registers this code as 53499-1391-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 53499-1391-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSchwabe North America, Inc.
Labeler code53499
First marketedAug 2011
Product typeHuman Otc Drug
Portfolio27 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a homeopathic sublingual tablet containing sanguinaria canadensis root, goldenseal, pulsatilla vulgaris, potassium chloride, and silicon dioxide. In homeopathic practice, these plant and mineral substances are traditionally used to address various conditions, though homeopathic products are marketed based on homeopathic tradition rather than FDA evaluation for effectiveness. The product is not approved by the FDA, and homeopathic remedies are not established as proven medical treatments by conventional standards.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintB;T
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

3 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCellulose Lactose monohydrate Magnesium stearate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alpha Sh 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 6 [hp_X]this 53499-1391-01 Schwabe 40 tablets — — FDA listed —
Alpha Sh 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 6 [hp_X] 68466-4191-01 Schwabe 40 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53499-1391-01 You're viewing this 4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACK 2011-08-18 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 6 [hp_X]/1 TABLET is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 53499-1391-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53499-1391-01, written without dashes as 53499139101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53499-1391-01, the first segment (53499) is the labeler code FDA assigned to Schwabe North America, Inc.; the middle segment (1391) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Schwabe North America, Inc. has reported a marketing end date of 2027-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Schwabe North America, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Indications and Usage Temporarily relieves these symptoms: helps decongest sinus openings and sinus passages, shrinks swollen nasal membranse, promotes sinus drainage.

⏱️ Dosage and Administration 63 words ▾

Dosage & Administration Directions: Sublingual medication. Place under tongue at least 15 minutes before or 30 minutes after eating, brushing teeth or drinking anything except water. Adults and Children 12 years and over: Take 2 tablets every 2 hours until relieved Children 6-12 years of age: take 1 tablet every 2 hours until relieved Children under 6 years of age: Consult a physician.

⚠️ Warnings 21 words ▾

Warnings Do not use this product for headache pain for more than 10 days (for adults) or 5 days (for children).

🆘 Overdosage 14 words ▾

Overdose In case of overdose, seek medical help or contact a Poison Control immediately.

🧪 Active Ingredient 15 words ▾

Active Ingedients Hydrastis canadensis 6X Kali muriaticum 3X Pulsatilla 6X Sanguinaria canadensis 6X Silicea 6X

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredient Cellulose Lactose monohydrate Magnesium stearate

🎯 Purpose 19 words ▾

Purpose Temporarily relieves these symptoms: helps decongest sinus openings and passages, shrinks swollen nasal membranes and promotes sinus drainage.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53499-1339-01 · Schwabe 53499-1491-06 · Schwabe →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.