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Calcium Carbonate 1 g/g Powder, 454 g — NDC 00395-0431-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Calcium Carbonate 1 g/g Powder, 454 g — NDC 0395-0431-01 (Billing 00395-0431-01)

by Humco Holding Group, Inc. · 454 g in 1 BOTTLE, PLASTIC

This is a package of 454 g of Calcium Carbonate 1 g/g Powder from Humco Holding Group, Inc., marketed since Jan 2008 and currently FDA-listed. It is this product's only package size.

NDC 00395-0431-01
🏷️ FDA NDC (as labeled) 0395-0431-01 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0395-0431-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0395 labeler · 0431 product · 01 package
Package marketed since
Nov 13, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
454 g per package
Barcode (UPC-A, from the NDC)
3 0395043101 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Calcium Carbonate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0573-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0561-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0578-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0568-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0579-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0560-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-0431-01
Product NDC 0395-0431
11-digit billing NDC 00395043101
NCPDP billing unit GM — per gram (weight)
UNII H0G9379FGK
Application # M001
SPL Set ID 8b207b49-d3fd-4108-b611-dca27c9dc78a
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-01-01
Route ORAL
Dosage form POWDER
Substance CALCIUM CARBONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79100007002900
GPI class Calcium Carbonate
GCN Seq No 002683
GCN 07860
HICL code 001163
Ingredient (HICL) Calcium Carbonate
HIC1 code U
Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants
HIC2 code U6
Therapeutic class — intermediate (HIC2) Pharmaceutical Adjuvants
HIC3 code U6W
Therapeutic class — specific (HIC3) Bulk Chemicals
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name CALCIUM CARBONATE POWDER
FDB brand name Calcium Carbonate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002683
  • GCN: 07860
  • GPI-14 (Medi-Span): 79100007002900
  • HICL (First Databank): 001163
  • AHFS class code: 56:04.00.00
Why two NDCs? The FDA registers this code as 0395-0431-01 — a 4-4-2 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 labeler segment → 00395-0431-01. 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.

Clinical

Label name CALCIUM CARBONATE POWDER Ingredient Calcium Carbonate
📗 Our plain-language guide HelloPharmacist
  • Most often it's an antacid. It relieves heartburn, acid indigestion, sour stomach and upset stomach tied to those symptoms. A few supplement products have other uses, like bone sup...
  • What is calcium carbonate usually used for?
  • You chew it when symptoms come on. Many labels say to chew or crush the tablets completely and not swallow them whole. The number of tablets varies by product, so read your label o...
  • Many labels say not to use the maximum dose for more than 2 weeks unless a doctor is supervising you. If your symptoms last longer than 2 weeks, check in with your doctor.
📖 Read our full Calcium Carbonate guide →
4
Nutrient depletion considerations

Calcium Carbonate may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Calcium Carbonate 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 gPer 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
00395-0431-01 You're viewing this Main listing 454 g in 1 BOTTLE, PLASTIC 2017-11-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Carbonate 1 g/gthis 00395-0431-01 Humco 454 g — — 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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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.

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.

🧪 Avoiding an ingredient? See Calcium Carbonate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesNone

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

LabelerHumco Holding Group, Inc.
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Humco Holding Group, Inc. labeler code 00395

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Use For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

⏱️ Dosage and Administration 35 words ▾

Directions Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

⚠️ Warnings 30 words ▾

Warnings Except under the supervision of a doctor: do not administer to children under 6 years of age. do not take more than 3 teaspoonfuls in a 24 hour period.

🧪 Active Ingredient 4 words ▾

Active Ingredient Calcium Carbonate

🧪 Inactive Ingredients 3 words ▾

Inactive Ingredients None

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Ask a Doctor Before Use If 13 words ▾

Ask a doctor before use if you are preganant or nursing a baby.

📄 When Using This Product 27 words ▾

do not use the maximum dosge of this product for more than 2 weeks except under the advice and supervision of a doctor or other health professional.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

📄 Package Label / Principal Display Panel 4 words ▾

Principal Display Panel CalCarb.jpg

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Calcium Carbonate — the ingredient across all brands.

Top reported reactions

Fatigue6,942
Nausea6,462
Diarrhoea5,709
Chronic Kidney Disease5,699
Pain5,439
Dyspnoea5,193
Vomiting5,013

Age at onset

Neonate89
Infant35
Child177
Adolescent182
Adult5,184
Elderly5,139

Reporter sex

73,758 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization29,678
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5,794 2,403
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Humco Holding Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Humco Holding Group, 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.
← 00395-0420-96 · Humco 00395-0467-16 · Humco →
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.