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Calcium Polycarbophil 625 mg Tablet, Film Coated, 90-count

by SHANDONG XINHUA PHARMACEUTICAL CO., LTD. · 90 TABLET, FILM COATED in 1 BOTTLE (58624-5003-1)
NDC 58624-5003-01
🏷️ FDA NDC (as labeled) 58624-5003-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 58624-5003-1
Product NDC 58624-5003
11-digit billing NDC 58624500301
RxCUI 308934
UNII 8F049NKY49
UPC 0358624500315
Application # M007
SPL Set ID ee06868b-f741-8da2-e053-2a95a90a9772
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-12
Route ORAL
Dosage form TABLET, FILM COATED
Substance CALCIUM POLYCARBOPHIL
Why two NDCs? The FDA registers this code as 58624-5003-1 — 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 → 58624-5003-01. 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 Bulk-forming laxatives class.

Drug family (ATC) Bulk-forming 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.

🏭 Manufacturer & labeler

LabelerSHANDONG XINHUA PHARMACEUTICAL CO., LTD.
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code58624
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio12 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 an over-the-counter tablet containing calcium polycarbophil, a type of bulk-forming agent. Calcium polycarbophil is commonly used to help relieve constipation by absorbing water in the intestines and forming a gel-like substance that makes stools easier to pass. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of medicine rather than being individually approved through a separate application.

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
ShapeOval
ImprintXH;C1
Size19 mm
ScoringScored — splits in 2
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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for 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 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

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

The official label also statesCaramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

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
Fiber Lax 625 mg 00536-4306-05 Rugby 500 tablets $0.059 — Availability likely —
Fiber Tabs 625 mg 00904-2500-91 Major 90 tablets $0.059 — Availability likely —
Calcium Polycarbophil 625 mg 70000-0067-01 LEADER/ 250 tablets $0.059 — Availability likely —
Foster and Thrive Fiber Laxative 147 625 mg 70677-1083-01 Strategic 90 tablets $0.059 — Availability likely —
Fiber caplets 147 625 mg 83324-0131-90 Chain 90 tablets $0.059 — Availability likely —
Walgreen Fiber Lax 625 mg 00363-0120-14 WALGREENS 140 tablets — — FDA listed —
up and up fiber therapy 625 mg 11673-0620-90 Target 140 tablets — — FDA listed —
Rite Aid Fiber Caplets 625 mg 11822-2025-00 RITE 250 tablets — — FDA listed —
Fiber Caplets 625 mg 21130-0021-40 SAFEWAY 140 tablets — — FDA listed —
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free 625 mg 24385-0125-27 Amerisourcebergen 90 capsules — — FDA listed —
Fiber Caplets 625 mg 30142-0132-14 THE 140 tablets — — FDA listed —
Fiber Laxative 625 mg 36800-0465-27 Topco 90 tablets — — FDA listed —
Fiber Laxative 625 mg 41163-0147-94 UNITED 140 tablets — — FDA listed —
Publix 625 mg 41415-0021-90 PUBLIX 90 tablets — — FDA listed —
Fiber Therapy 625 mg 49035-0147-94 Wal-Mart 140 tablets — — FDA listed —
Goodsense Fiber laxative 147 625 mg 50804-0147-94 GoodSense 140 tablets — — FDA listed —
Fiber Caps 625 mg 53041-0147-27 Guardian 90 tablets — — FDA listed —
Fiber laxative 625 mg 53943-0147-27 Discount 90 tablets — — FDA listed —
Fiber Laxative 625 mg 54257-0379-07 Magno-Humphries, 90 tablets — — FDA listed —
Fiber Laxative 625 mg 54257-0479-07 Magno-Humphries, 90 tablets — — FDA listed —
Fiber Lax 625 mg 55289-0949-30 PD-Rx 30 tablets — — FDA listed —
Fiber Laxative 625 mg 57896-0459-09 Geri-Care 90 tablets — — FDA listed —
Calcium Polycarbophil 625 mgthis 58624-5003-01 SHANDONG 90 tablets — — FDA listed —
Quality Choice 625 mg 63868-0530-90 QUALITY 90 tablets — — FDA listed —
Best Choice 625 mg 63941-0023-90 BEST 90 tablets — — FDA listed —
Premier Value 625 mg 68016-0220-25 PHARMACY 250 tablets — — FDA listed —
Calcium Polycarbophil 625 mg 69842-0846-02 CVS 250 tablets — — FDA listed —
Calcium Polycarbophil 625 mg 70369-0006-08 CITRAGEN 120 tablets — — FDA listed —
Amazon Fiber Caplets 625 mg 72288-0201-40 AMAZON.COM 140 tablets — — FDA listed —
Fiber Laxative Caplets 625 mg 77333-0120-50 Gendose 50 tablets — — FDA listed —
Meijer Fiber Caplets 625 mg 79481-1205-00 MEIJER 250 tablets — — FDA listed —
Fibercon 625 mg 80070-0500-14 Foundation 140 tablets — — FDA listed —
Quality Choice Fiber Caplets 625 mg 83324-0276-14 QUALITY 140 tablets — — FDA listed —
Equalactin Laxative 625 mg 69846-0000-26 NUMARK 24 tablets — — Discontinued —
Fibercon 625 mg 63029-0170-14 Medtech 140 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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
58624-5003-01 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (58624-5003-1) 2023-04-12 Active

🧭 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 FDA registers it as 58624-5003-1, 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: 58624-5003-01, written without dashes as 58624500301. 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 58624-5003-01, the first segment (58624) is the labeler code FDA assigned to SHANDONG XINHUA PHARMACEUTICAL CO., LTD.; the middle segment (5003) 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: this package is listed as actively marketed, with no marketing end date reported by SHANDONG XINHUA PHARMACEUTICAL CO., LTD.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SHANDONG XINHUA PHARMACEUTICAL CO., LTD. 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 14 words ▾

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

⏱️ Dosage and Administration 79 words ▾

Directions take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my cause choking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children over 12 years 2 caplets, 1 to 4 times per day children under 12 years ask a doctor

⚠️ Warnings 212 words ▾

Choking : Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting difficulty in swallowing a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product do not use for more than 7 days unless directed by a doctor do not take more than 8 caplets in a 24-hour period unless directed by a doctor Stop use and ask a doctor if you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 16 words ▾

Drug Facts Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

🧪 Inactive Ingredients 14 words ▾

Caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

🎯 Purpose 3 words ▾

Purpose Bulk-forming laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58624-5001-02 · Shandong 58624-6001-00 · Shandong →
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.