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Laxative Bisacodyl 5 mg Tablet, Delayed Release, 100-count — NDC 83586-116-01 (Billing 83586-0116-01)

by HHH Pharmaceuticals · 100 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Laxative Bisacodyl 5 mg Tablet, Delayed Release from HHH Pharmaceuticals, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 83586-0116-01
🏷️ FDA NDC (as labeled) 83586-116-01 billing pads the product segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83586-116-01
Product NDC 83586-116
11-digit billing NDC 83586011601
RxCUI 308753
UNII 10X0709Y6I
UPC 0383586116014
Application # 505G(a)(3)
SPL Set ID afb39544-c509-490c-ad42-ba68ebbf986b
Established class (EPC) Stimulant Laxative
Physiologic effect Increased Large Intestinal Motility; Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-28
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance BISACODYL
Quick answers
  • RxCUI (RxNorm): 308753
Why two NDCs? The FDA registers this code as 83586-116-01 — 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 → 83586-0116-01. 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.

RxNorm drug class

This medicine belongs to the Stimulant Laxative class.

Pharmacologic class Stimulant Laxative
Drug family (ATC) Contact laxatives, Enemas
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

Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl 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
  • It relieves occasional constipation and irregularity. The Fleet enema is also used for fecal impaction and to clear residue after a barium test. It is meant for short-term use.
  • It depends on the form. Tablets usually work in 6 to 12 hours. Suppositories usually work in 15 minutes to 1 hour. The Fleet enema usually works in 5 to 20 minutes.
  • Not right away. Wait at least 1 hour after an antacid or milk before taking tablets. Swallow tablets whole with water and do not chew or crush them.
  • Can I take the tablets with an antacid or milk?
📖 Read our full Bisacodyl guide →
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.
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
83586-0116-01 You're viewing this Main listing 100 TABLET, DELAYED RELEASE in 1 BOTTLE 2025-07-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bisacodyl 5 mg 00904-6407-61 Major 10 tablets $0.044 — Availability likely —
Bisacodyl 5 mg 00904-6748-17 Major 25 tablets $0.044 — Availability likely —
Womens Gentle Laxative 5 mg 46122-0429-63 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 46122-0529-63 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 46122-0767-11 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 70000-0221-01 Cardinal 10 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 70000-0538-01 CARDINAL 100 tablets $0.044 — Availability likely —
Laxative 5 mg 70677-1086-01 Strategic 10 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 83324-0033-30 Chain 15 tablets $0.044 — Availability likely —
Laxative 5 mg 83324-0061-30 Chain 25 tablets $0.044 — Availability likely —
Fleet 5 mg 00132-0401-25 C.B. 25 tablets — — FDA listed —
Gentle Laxative 5 mg 00363-0327-03 Walgreen 10 tablets — — FDA listed —
Laxative 5 mg 00363-6760-01 Walgreen 15 tablets — — FDA listed —
up and up gentle laxative 5 mg 11673-0116-25 Target 25 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 11673-0151-52 TARGET 25 tablets — — FDA listed —
Bisacodyl 5 mg 11673-0182-52 TARGET 25 tablets — — FDA listed —
laxative for women 5 mg 11822-0676-05 Rite 15 tablets — — FDA listed —
Laxative 5 mg 11822-0790-01 Rite 25 tablets — — FDA listed —
Gentle Laxative 5 mg 21130-0410-20 BETTER 200 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 21130-0555-30 BETTER 30 tablets — — FDA listed —
Gentle Overnight Laxative 5 mg 21130-0827-06 Better 200 tablets — — Discontinued —
Laxative Gentle 5 mg 30142-0827-12 Kroger 25 tablets — — FDA listed —
Gentle Laxative 5 mg 36800-0327-03 Topco 10 tablets — — FDA listed —
Gentle Laxative 5 mg 37808-0327-15 H 25 tablets — — FDA listed —
Womens Laxative 5 mg 37808-0676-11 H 15 tablets — — Discontinued —
Gentle Laxative 5 mg 37808-0680-11 H 15 tablets — — FDA listed —
Laxative 5 mg 37835-0241-01 Bi-Mart 100 tablets — — FDA listed —
Gentle Laxative 5 mg 37835-0244-30 Bi-Mart 15 tablets — — FDA listed —
Gentle Laxative 5 mg 41163-0607-52 United 18 tablets — — FDA listed —
Dulcolax Simulant Laxative 5 mg 41167-0101-00 Chattem, 8 tablets — — FDA listed —
Dulcolax Stimulant Laxative 5 mg 41167-0200-01 Chattem, 10 tablets — — FDA listed —
Dulcolax Pink Stimulant Laxative 5 mg 41167-0290-05 Chattem, 25 tablets — — FDA listed —
Dulcolax Stimulant Laxative 5 mg 41167-0400-01 Chattem, 10 tablets — — FDA listed —
Bisacodyl 5 mg 41226-0003-52 KROGER 25 tablets — — FDA listed —
Womens Laxative 5 mg 41226-0151-52 KROGER 25 tablets — — FDA listed —
gentle laxative 5 mg 41250-0339-56 Meijer 25 tablets — — FDA listed —
Womens gentle laxative 5 mg 41250-0676-11 Meijer 15 tablets — — FDA listed —
Publix Stimulant Laxative 5 mg 41415-0116-25 PUBLIX 25 tablets — — FDA listed —
Publix Women Laxative 5 mg 41415-0121-30 PUBLIX 30 tablets — — FDA listed —
Gentle Laxative 5 mg 49035-0327-12 Wal-Mart 100 tablets — — FDA listed —
Gentle Laxative 5 mg 49035-0706-12 Wal-Mart 100 tablets — — FDA listed —
Stimulant Laxative 5 mg 49483-0003-00 TIME 100000 tablets — — FDA listed —
Bisacodyl Laxative 5 mg 50804-0327-56 Geiss, 25 tablets — — FDA listed —
Gentle Laxative 5 mg 50844-0327-15 L.N.K. 25 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 53943-0676-01 Discount 15 tablets — — FDA listed —
Gentle Laxative 5 mg 53943-0677-01 Discount 15 tablets — — FDA listed —
Bisacodyl 5 mg 55154-6897-00 Cardinal 1 tablet — — FDA listed —
Laxative 5 mg 55319-0327-15 Family 25 tablets — — FDA listed —
Gentle Laxative 5 mg 55319-0697-56 Family 25 tablets — — FDA listed —
Laxomil 5 mg 55758-0504-01 Pharmadel 24 tablets — — FDA listed —
Gentle Laxative 5 mg 55910-0327-62 DOLGENCORP, 15 tablets — — FDA listed —
Laxative Gentle 5 mg 55910-0723-62 DOLGENCORP, 15 tablets — — FDA listed —
Laxative 5 mg 55910-0792-56 DOLGENCORP, 25 tablets — — FDA listed —
Extra Gentle Laxative 5 mg 55910-0954-52 DOLGENCORP 25 tablets — — FDA listed —
laxative 5 mg 56062-0327-56 Publix 25 tablets — — FDA listed —
Laxative 5 mg 56062-0976-01 Publix 15 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 57896-0441-01 Geri-Care 100 tablets — — FDA listed —
Gentle Laxative 5 mg 59779-0327-03 CVS 10 tablets — — FDA listed —
C-Lax Laxative 5 mg 59779-0676-13 CVS 250 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 63868-0573-30 CHAIN 15 tablets — — FDA listed —
Gentle Laxative Stimulant Laxative 5 mg 63868-0908-25 QUALITY 25 tablets — — FDA listed —
Stimulant Laxative Enteric Coated 5 mg 66424-0002-01 SDA 100 tablets — — FDA listed —
Laxative Gentle 5 mg 67091-0215-25 WinCo 25 tablets — — FDA listed —
Laxative Women 5 mg 67091-0286-30 WinCo 15 tablets — — Discontinued —
Laxative 5 mg 67091-0452-24 WinCo 15 tablets — — FDA listed —
Bisacodyl 5 mg 68016-0688-10 Chain 100 tablets — — FDA listed —
Bisacodyl Stimulant Laxative 5 mg 68163-0116-25 Raritan 25 tablets — — FDA listed —
Womens Laxative 5 mg 68998-0398-85 Marc 25 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 68998-0404-92 Marc 25 tablets — — FDA listed —
Bisacodyl 5mg 5 mg 69168-0398-92 Allegiant 25 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 69168-0404-03 Allegiant 250 tablets — — FDA listed —
stimulant laxative 5 mg 69452-0541-83 BIONPHARMA 300 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 69842-0089-52 CVS 25 tablets — — FDA listed —
Womens Laxative Enteric Coated 5 mg 70000-0570-01 CARDINAL 25 tablets — — FDA listed —
GOOD REMEDIES GENTLE Laxative 5 mg 70692-0167-52 Strive 25 tablets — — FDA listed —
RIGHT REMEDIES OVERNIGHT Laxative 5 mg 70692-0761-31 Strive 300 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 71335-1531-00 Bryant 25 tablets — — FDA listed —
Bisacodyl 5 mg 71335-2010-00 Bryant 25 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 71610-0453-02 Aphena 2 tablets — — FDA listed —
Bisacodyl 5 mg 71610-0700-02 Aphena 2 tablets — — FDA listed —
Bisacodyl 5 mg 72090-0131-01 Pioneer 300 tablets — — FDA listed —
Laxative 5 mg 76162-0676-01 TOPCO 15 tablets — — FDA listed —
SIMPEX Bisacodyl laxative 5 mg 76457-0003-00 Simpex 100 tablets — — FDA listed —
Gentle Laxative 5 mg 79903-0178-08 Wal-Mart 8 tablets — — FDA listed —
Laxative 5 mg 80513-0409-20 Advanced 200 tablets — — FDA listed —
Laxative 5 mgthis 83586-0116-01 HHH 100 tablets — — FDA listed —
Bisacodyl 5 mg 84324-0132-01 NUVICARE 100 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 85766-0148-00 Sportpharm 1000 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 85828-0404-92 Grocery 25 tablets — — FDA listed —
Laxative 5 mg 79481-6760-01 Meijer 15 tablets — — FDA listed —
Bisacodyl 5 mg 83586-0012-00 HHH 310000 tablets — — FDA listed —
Stimulant Laxative Gentle 5 mg 51316-0327-03 CVS 10 tablets — — FDA listed —
Gentle Laxative 5 mg 50804-0329-56 Geiss, 25 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesColloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

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

LabelerHHH Pharmaceuticals
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code83586
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio9 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.

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

⏱️ Dosage and Administration 44 words ▾

Directions take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years 1 tablets once a day children under 6 years ask a doctor

⚠️ Warnings 138 words ▾

Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness, and cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week 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 (1-800-222-1222) right away.

📦 Storage and Handling 15 words ▾

Other information store at controlled room temperature 20°-25°C (68°-77°F) read all product information before use.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Bisacodyl USP, 5 mg

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

🎯 Purpose 2 words ▾

Purpose Laxative

📄 Do Not Use 9 words ▾

Do not use if you cannot swallow without chewing

📄 Ask a Doctor Before Use If 25 words ▾

Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks

📄 When Using This Product 30 words ▾

When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness, and cramps

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 13 words ▾

Questions or comments? Call + 1-848-235-5293 Monday through Friday 9AM – 5PM EST

📄 Package Label / Principal Display Panel 4 words ▾

Principal Display Panel label

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 — Not published for this NDC No photo available yet for this listing.
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 HHH Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HHH Pharmaceuticals 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.
← 83586-0115-01 · HHH 83586-0160-01 · HHH →
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.