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Senna-Lax Sennosides 8.6 mg Tablet, 100-count — NDC 53041-0159-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Senna-Lax Sennosides 8.6 mg Tablet, 100-count — NDC 53041-159-16 (Billing 53041-0159-16)

by Guardian Drug Company · 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Senna-Lax Sennosides 8.6 mg Tablet from Guardian Drug Company, marketed since Feb 2002 and currently FDA-listed.

NDC 53041-0159-16
🏷️ FDA NDC (as labeled) 53041-159-16 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Product page 53041-0159-14 Also comes in: 50 tablets 53041-159-14
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 53041-159-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53041 labeler · 159 product · 16 package
Package marketed since
Feb 2, 2002
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5304115916 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53041-159-16
Product NDC 53041-159
11-digit billing NDC 53041015916
RxCUI 312935
UNII 3FYP5M0IJX
Application # M007
SPL Set ID d3ee7288-986e-44a6-8aa2-05405210c875
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-02-02
Route ORAL
Dosage form TABLET
Substance SENNOSIDES
Quick answers
  • RxCUI (RxNorm): 312935
Why two NDCs? The FDA registers this code as 53041-159-16 — a 5-3-2 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 product segment → 53041-0159-16. 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.

RxNorm drug class

This medicine belongs to the Contact laxatives class.

Drug family (ATC) Contact laxatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Senna typically produces a bowel movement within 6 to 12 hours. That's why most people take it at bedtime — so it can do its job overnight and you get results in the morning. If no...
  • How long does it take for senna to work?
  • Senna is designed for short-term, occasional use. You should not use it for more than 1 week unless your doctor specifically tells you it's okay. Using laxatives too often or for t...
  • Laxatives like senna can affect how your body absorbs other medications. To be safe, take senna at least 2 hours before or after any other drugs you use. It's always a good idea to...
📖 Read our full Senna guide →
3
Nutrient depletion considerations

Sennosides (OTC drug) may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sennosides (OTC drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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.
Try another pack size: 50 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53041-0159-14 53041-159-14 Main listing 1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE 2002-02-02 — Active
53041-0159-16 You're viewing this 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE 2002-02-02 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 1 bottle in 1 carton / 100 tablet in 1 bottle.
How does this package differ from NDC 53041-0159-14?
Both are Senna-Lax Sennosides 8.6 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 53041-0159-14 is the 50 tablets package.
What NDC number is used to bill for this package of Senna-Lax Sennosides 8.6 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vegetable Laxative 8.6 mg 63868-0579-01 CHAIN 100 tablets $0.021 — FDA listed —
Senna Laxative 8.6 mg 70677-0164-01 Strategic 100 tablets $0.024 — FDA listed —
Senna Laxative 8.6 mg 70677-1247-01 Strategic 150 tablets $0.026 — Availability likely —
Sennosides 8.6 mg 00904-7252-60 Major 100 tablets $0.026 — Availability likely —
Senna 8.6 mg 46122-0702-78 AmerisourceBergen 100 tablets $0.026 — Availability likely —
Sennosides 8.6 mg 70000-0610-01 LEADER/ 50 tablets $0.026 — Availability likely —
Senna Laxative 8.6 mg 70677-1097-01 Strategic 100 tablets $0.026 — Availability likely —
Senna 8.6 mg 82568-0006-01 AARNA 100 tablets $0.026 — Availability likely —
Senna 8.6 mg 83324-0004-01 QUALITY 100 tablets $0.026 — Availability likely —
Senokot 8.6 mg 67618-0300-10 Atlantis 100 tablets $0.247 — Availability likely —
Senna laxative 8.6 mg 00363-0138-10 Walgreens 100 tablets — — FDA listed —
Senna 8.6 mg 00363-8820-10 Walgreens 100 tablets — — FDA listed —
Senna Time 8.6 mg 00615-8402-39 NCS 30 tablets — — FDA listed —
Natural Senna Laxative 8.6 mg 00761-0790-02 Basic 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 00761-0798-02 Basic 100 tablets — — FDA listed —
Sennosides 8.6 mg 10135-0314-01 Marlex 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 11673-0191-01 TARGET 100 tablets — — FDA listed —
Senna 8.6 mg 11822-0298-02 Rite 100 tablets — — FDA listed —
Senna Tabs 8.6 mg 16103-0363-08 Pharbest 100 tablets — — FDA listed —
Vegetable Laxative 8.6 mg 21130-0998-01 BETTER 100 tablets — — FDA listed —
Kroger Senna Laxative Regular Strength 8.6 mg 30142-0710-00 KROGER 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 30142-0752-10 The 100 tablets — — FDA listed —
Laxative Senna 8.6 mg 36800-0984-01 TOPCO 100 tablets — — FDA listed —
Senna 8.6 mg 37808-0675-10 H 100 tablets — — FDA listed —
Senna 8.6 mg 37808-0782-10 H 100 tablets — — FDA listed —
Natural Laxative 8.6 mg 37835-0211-01 Bi-Mart 100 tablets — — FDA listed —
Senna laxative 8.6 mg 41163-0631-10 United 100 tablets — — FDA listed —
Senna laxative 8.6 mg 41163-0775-10 United 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 41163-0782-10 United 100 tablets — — FDA listed —
Meijer Senna Laxative Regular Strength 8.6 mg 41250-0445-00 MEIJER, 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 43063-0838-10 PD-Rx 10 tablets — — FDA listed —
Senna Time 8.6 mg 49483-0080-00 TIME 100000 tablets — — FDA listed —
Senna Laxative 8.6 mg 50804-0372-01 Good 100 tablets — — FDA listed —
Senna laxative 8.6 mg 50804-0882-10 Good 100 tablets — — Discontinued —
Sennosides 8.6 mg 51316-0112-02 CVS 250 tablets — — FDA listed —
CAREALL Sennosides 8.6 mg 51824-0058-01 New 100 tablets — — FDA listed —
Senna-Lax 8.6 mgthis 53041-0159-16 Guardian 100 tablets — — FDA listed —
Senna Natural Vegetable 8.6 mg 53329-0986-30 Medline 100 tablets — — FDA listed —
Sennosides Natural Laxative 8.6 mg 54257-0679-02 Magno-Humphries, 100 tablets — — FDA listed —
Sennosides 8.6 mg 55154-2347-00 Cardinal 1 tablet — — FDA listed —
Exchange select 8.6 mg 55301-0107-00 ARMY 100 tablets — — FDA listed —
Senna 8.6 mg 55319-0298-12 Family 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 55910-0208-12 DOLGENCORP, 100 tablets — — FDA listed —
Senna laxative 8.6 mg 55910-0882-10 Dolgencorp, 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 55910-0885-10 Dolgencorp, 100 tablets — — FDA listed —
Geri-kot 8.6 mg 57896-0434-01 Geri-Care 100 tablets — — FDA listed —
Geri-kot 8.6 mg 57896-0454-01 Geri-Care 100 tablets — — Discontinued —
Sennosides 8.6 mg 62993-0001-01 Morepen 30 tablets — — FDA listed —
Vegetable Laxative 8.6 mg 63561-0188-01 Granulation 100 tablets — — FDA listed —
Senna laxative 8.6 mg 63941-0882-10 Best 100 tablets — — FDA listed —
Senna-Lax 8.6 mg 68998-0373-01 Marc 100 tablets — — FDA listed —
Senna Lax 8.6 mg 69168-0371-17 Allegiant 300 tablets — — FDA listed —
Senna 8.6 mg 69618-0064-01 Reliable 100 tablets — — FDA listed —
Sennosides 8.6 mg 69842-0220-08 CVS 500 tablets — — FDA listed —
Geri-kot 8.6 mg 71335-1806-01 Bryant 100 tablets — — FDA listed —
Senna 8.6 mg 71335-2360-01 Bryant 100 tablets — — FDA listed —
Sennosides 8.6 mg 71335-2660-01 Bryant 100 tablets — — FDA listed —
Senna 8.6 mg 71399-1017-01 Akron 100 tablets — — FDA listed —
Senna Natural Relief 8.6 mg 72090-0031-60 Pioneer 600 tablets — — FDA listed —
Senna Laxative 8.6 mg 72090-0041-01 Pioneer 300 tablets — — FDA listed —
Senna Laxative 8.6 mg 72476-0875-10 Care 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 72476-0882-10 Care 100 tablets — — FDA listed —
Sennosides 8.6 mg 72789-0283-10 PD-Rx 10 tablets — — FDA listed —
Senna-Tabs 8.6 mg 73057-0363-08 Ulai 100 tablets — — FDA listed —
Senna Lax 8.6 mg 76162-0005-98 TopCo 200 tablets — — FDA listed —
Vegetable Laxative 8.6 mg 79903-0064-10 Wal-Mart 100 tablets — — FDA listed —
Vegetable Laxative 8.6 mg 79903-0322-10 Walmart 100 tablets — — FDA listed —
Senna Laxative 8.6 mg 80136-0434-01 Heartland 100 tablets — — FDA listed —
Senna 8.6 mg 82804-0143-04 Proficient 4 tablets — — FDA listed —
Senna Laxative 8.6 mg 84324-0012-01 NUVICARE 200 tablets — — FDA listed —
Dr Simi Regular Strength Sennosides 8.6mg 8.6 mg 85786-0501-50 Farmacias 50 tablets — — FDA listed —
Laxative 8.6 mg 55910-0659-10 Dolgencorp, 100 tablets — — FDA listed —
Sennosides 8.6 mg 87717-0501-01 Morepen 1000 tablets — — FDA listed —
HyVee Regular Strength Sennosides Laxative 8.6 mg 42507-0155-01 HyVee 100 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

🏛️
2002
On the market since
Feb 2002
📍
2026
Currently FDA-listed
24 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.

What it looks like

Color brown
ShapeRound
ImprintG159
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • 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.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescrospovidone, dextrose, magnesium stearate, microcrystalline cellulose, pregelatinized starch

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.

Manufacturer & labeler

LabelerGuardian Drug Company
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code53041
First marketedFeb 2002
Product typeHuman Otc Drug
Portfolio46 products on file

More NDCs from Guardian Drug Company labeler code 53041

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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Uses relieves: occasional constipation (irregularity)

⏱️ Dosage and Administration 118 words ▾

Directions take preferably at bedtime expect results in 6-12 hours adults and children 12 years and over do not exceed 8 tablets in 24 hours children 6 to under 12 years do not exceed 4 tablets in 24 hours children 2 to under 6 years do not exceed 2 tablets in 24 hours do not exceed the maximum dosage of this product adults and children 12 years and over 2 tablets once daily (maximum: 4 tablets twice a day) children 6 to under 12 years 1 tablet once daily (maximum: 2 tablets twice a day) children 2 to under 6 years 1/2 tablet once daily (maximum: 1 tablet twice a day) childrem under 2 years ask a doctor

⚠️ Warnings 71 words ▾

Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

📦 Storage and Handling 21 words ▾

Other information do not use if printed seal under cap is torn or missing store at room temperature avoid excessive humidity

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Sennosides 8.6 mg

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients crospovidone, dextrose, magnesium stearate, microcrystalline cellulose, pregelatinized starch

🎯 Purpose 2 words ▾

Purpose Laxative

📄 Do Not Use 71 words ▾

Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

📄 Ask a Doctor Before Use If 56 words ▾

Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

📄 Stop Use and Ask a Doctor If 29 words ▾

stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

🤰 If Pregnant or Breast-Feeding 30 words ▾

If pregnant or breast-feeding, ask a health professional before use keep out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

📄 Package Label / Principal Display Panel 25 words ▾

PDP Compare to the active ingredient in SENOKOT ® Senna-Lax Natural Vegetable Laxative Sennosides / Laxative For Gentle, Overnight Relief of Constipation 100 Tablets Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Guardian Drug Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 tablets (53041-0159-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Guardian Drug Company 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.
← 53041-0147-27 · Guardian 53041-0161-68 · Guardian →
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.