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Calcium Carbonate 1250 mg/5mL Suspension — NDC 00121-0766-16 package photo

Calcium Carbonate 1250 mg/5mL Suspension

by PAI Holdings, LLC dba PAI Pharma · 12 BOTTLE in 1 CASE (0121-0766-16) / 473 mL in 1 BOTTLE
NDC 00121-0766-16
🏷️ FDA NDC (as labeled) 0121-0766-16 billing pads the labeler 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

⚠️
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

FDA NDC (as labeled) 0121-0766-16
Product NDC 0121-0766
11-digit billing NDC 00121076616
NCPDP billing unit ML — per mL (volume)
RxCUI 308891
UNII H0G9379FGK
Application # M001
SPL Set ID d89f3184-7081-4e16-a504-9214283891f6
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 2004-12-01
Route ORAL
Dosage form SUSPENSION
Substance CALCIUM CARBONATE
GPI-14 48300010001815
GPI class Calcium Carbonate Antacid
GCN Seq No 002684
GCN 07872
HICL code 000581
Ingredient (HICL) Calcium Carbonate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1F
Therapeutic class — specific (HIC3) Calcium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name CALCIUM CARB 1,250 MG/5 ML SUS
FDB brand name Calcium Carbonate
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0121-0766-16 — 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 → 00121-0766-16. 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 Calcium compounds class.

Drug family (ATC) Calcium compounds, Calcium
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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedDec 2004
Product typeHuman Otc Drug
Portfolio142 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

Label name CALCIUM CARB 1,250 MG/5 ML SUS Ingredient Calcium Carbonate
📗 Our plain-language guide HelloPharmacist
  • Most people use it as a fast-acting antacid to get quick relief from heartburn, acid indigestion, sour stomach, or an upset stomach. You'll find it in brands like Tums, Rolaids, an...
  • What is calcium carbonate actually used for?
  • Don't use the maximum daily dose for more than 2 weeks in a row without talking to a doctor first. If your heartburn or stomach symptoms keep coming back or don't improve, that's y...
  • How long can I keep taking this before I should see a 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.

💊 What it looks like

Color pink
FlavorBubble Gum
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 5101OP7P2I
    Saccharin calcium is an artificial sweetener made from saccharin combined with calcium. It's used in medicines to make tablets or liquids taste better so they're easier to take.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statescalcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.020 $115.22 / 5676 ml
Medicaid paysCMS SDUD · 12 mo $0.0368 $208.88 / 5676 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2021 Nov 2022 Feb 2026 Aug 2026 $0.021 $0.015
▲ Up 34% over the last 18 months.
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
Calcium Carbonate 1250 mg/5mLthis 00121-0766-16 PAI 12 bottles $0.020 — Availability likely —
Calcium Carbonate 1250 mg/5mL 00121-4766-05 PAI 10 cups — — FDA listed —
Calcium Carbonate 1250 mg/5mL 17856-3117-03 Atlantic 5 ml — — 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

🏛️
2004
On the market since
Dec 2004
📍
2026
Currently FDA-listed
22 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00121-0766-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
26.4K
Units reimbursed last 4 qtrs
6.9M
Gross reimbursed last 4 qtrs
$252.6K
Avg / prescription
$9.58
Avg / unit
$0.0368
Latest quarter Q4 2025
6.3KRx
Medicaid pays / mL
$0.0368
gross reimbursed
vs
NADAC / mL
$0.0203
acquisition cost
=
Spread
+$0.0165
+81% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
49% FFS 51% MCO
Fee-for-service · 13,036 Rx Managed care · 13,333 Rx
State Medicaid map
Alaska: no data reported AK Maine: 34,334 units · 2,461 per 100k residents ME Washington: 162,323 units · 2,078 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 560,988 units · 9,778 per 100k residents MN Wisconsin: 193,731 units · 3,278 per 100k residents WI Michigan: 225,120 units · 2,243 per 100k residents MI New York: 837,980 units · 4,282 per 100k residents NY Vermont: 23,081 units · 3,567 per 100k residents VT New Hampshire: no data reported NH Oregon: 93,872 units · 2,218 per 100k residents OR Nevada: 91,576 units · 2,867 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 29,272 units · 913 per 100k residents IA Illinois: 207,893 units · 1,657 per 100k residents IL Indiana: 263,884 units · 3,846 per 100k residents IN Ohio: 501,938 units · 4,259 per 100k residents OH Pennsylvania: 825,990 units · 6,373 per 100k residents PA New Jersey: 219,399 units · 2,362 per 100k residents NJ Massachusetts: 393,477 units · 5,620 per 100k residents MA California: no data reported CA Utah: 43,211 units · 1,265 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 129,253 units · 2,086 per 100k residents MO Kentucky: 248,735 units · 5,496 per 100k residents KY West Virginia: no data reported WV Virginia: 208,449 units · 2,392 per 100k residents VA Maryland: 26,233 units · 424 per 100k residents MD Connecticut: 59,899 units · 1,656 per 100k residents CT Rhode Island: 8,874 units · 810 per 100k residents RI Arizona: 152,354 units · 2,050 per 100k residents AZ New Mexico: 70,084 units · 3,315 per 100k residents NM Kansas: no data reported KS Arkansas: 54,643 units · 1,782 per 100k residents AR Tennessee: 94,765 units · 1,330 per 100k residents TN North Carolina: no data reported NC South Carolina: 110,336 units · 2,054 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 94,740 units · 2,071 per 100k residents LA Mississippi: 76,735 units · 2,610 per 100k residents MS Alabama: no data reported AL Georgia: 17,266 units · 157 per 100k residents GA D.C.: 75,561 units · 11,128 per 100k residents DC Hawaii: 44,438 units · 3,097 per 100k residents HI Texas: 674,214 units · 2,210 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
15711,128
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 11,128 /100k
2 Minnesota 9,778 /100k
3 Pennsylvania 6,373 /100k
4 Massachusetts 5,620 /100k
5 Kentucky 5,496 /100k
6 New York 4,282 /100k
7 Ohio 4,259 /100k
8 Indiana 3,846 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00121-0766-16 You're viewing this 12 BOTTLE in 1 CASE (0121-0766-16) / 473 mL in 1 BOTTLE 2004-12-01 Active

📄 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
🎯 Indications and Usage 13 words ▾

Uses Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

⏱️ Dosage and Administration 23 words ▾

Directions Shake well before using. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

⚠️ Warnings 55 words ▾

Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks. Keep out of reach of children.

📦 Storage and Handling 52 words ▾

Other information store at 20° - 25°C (68° - 77°F) do not freeze Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms: NDC 0121-0766-16: 16 fl oz (473 mL) bottle NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.

🧪 Active Ingredient 17 words ▾

Active ingredient (in each 5 mL teaspoonful) Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium)

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

🎯 Purpose 2 words ▾

Purpose Antacid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0759-08 · PAI 00121-0770-01 · Pharmaceutical →
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.