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Tums calcium carbonate 500 mg Tablet, 150-count — NDC 00135-0071-27 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tums calcium carbonate 500 mg Tablet, 150-count — NDC 0135-0071-27 (Billing 00135-0071-27)

by Haleon US Holdings LLC · 150 TABLET in 1 BOTTLE

This is a package of 150 tablets of Tums calcium carbonate 500 mg Tablet from Haleon US Holdings LLC, marketed since Mar 2010 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00135-0071-27
🏷️ FDA NDC (as labeled) 0135-0071-27 billing pads the labeler segment with a zero
This package
Contains150-count Pack sizes2 compare ↓
Main listing for product 0135-0071 · Also comes in: 12 tablets 0135-0071-48
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

⚠️
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) 0135-0071-27
Product NDC 0135-0071
11-digit billing NDC 00135007127
NCPDP billing unit EA — each (per item)
RxCUI 210117, 308907
UNII H0G9379FGK
Application # M001
SPL Set ID 35f79dcf-1743-4d9f-aba5-5ead6b056309
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 2010-03-10
Route ORAL
Dosage form TABLET
Substance CALCIUM CARBONATE

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

GPI-14 48300010000510
GPI class Tums
GCN Seq No 002689
GCN 07893
HICL code 001163
Ingredient (HICL) Calcium Carbonate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name TUMS TABLET CHEWABLE
FDB brand name Tums
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002689
  • GCN: 07893
  • GPI-14 (Medi-Span): 48300010000510
  • HICL (First Databank): 001163
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 210117
Why two NDCs? The FDA registers this code as 0135-0071-27 — 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 → 00135-0071-27. 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.

Clinical

Label name TUMS TABLET CHEWABLE Ingredient Calcium Carbonate
📖 What it is MedlinePlus · NLM

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 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 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: 12 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
00135-0071-27 You're viewing this Main listing 150 TABLET in 1 BOTTLE 2010-03-10 — Active
00135-0071-48 0135-0071-48 12 TABLET in 1 PACKAGE 2010-03-10 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 150-count package — 150 tablet in 1 bottle.
How does this package differ from NDC 00135-0071-48?
Both are Tums calcium carbonate 500 mg Tablet — the drug itself is identical. This page's package is the 150-count one, while NDC 00135-0071-48 is the 12 tablets package.
What NDC number is used to bill for this package of Tums calcium carbonate 500 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
Quality Choice Chewable Antacid Assorted Fruit 500 mg 63868-0047-15 Chain 150 tablets $0.014 — FDA listed —
QC Regular Strength 500 mg 63868-0130-66 QUALITY 66 tablets $0.014 — FDA listed —
Rugby Cal-Gest Antacid Assorted Flavors 500 mg 00536-1007-15 Rugby 150 tablets $0.017 — Availability likely —
Rugby 500 mg 00536-1048-15 Rugby 150 tablets $0.017 — Availability likely —
Major Regular Strength Assorted Flavors 500 mg 00904-6412-92 Major 150 tablets $0.017 — Availability likely —
Regular Strength Antacid 500 mg 24385-0478-47 Amerisource 150 tablets $0.017 — Availability likely —
Good Neighbor Pharmacy Antacid Regular Strength 500 mg 24385-0485-47 AmerisourceBergen 150 tablets $0.017 — Availability likely —
Antacid Peppermint Flavour Regular Strength 500 mg 68084-0988-32 American 1 tablet $0.017 — Availability likely —
Regular Strength Antacid Assorted Fruit 500 mg 70000-0034-01 CARDINAL 150 tablets $0.017 — Availability likely —
Foster and Thrive Regular Strength Antacid 500 mg 70677-1075-01 Strategic 150 tablets $0.017 — Availability likely —
Foster and Thrive Regular Strength Antacid Peppermint 500 mg 70677-1081-01 Strategic 150 tablets $0.017 — Availability likely —
QUALITY CHOICE Regular Strength 500 mg 83324-0315-15 QUALITY 150 tablets $0.017 — Availability likely —
QUALITY CHOICE Regular Strength 500 mg 83324-0316-15 QUALITY 150 tablets $0.017 — Availability likely —
Quality Choice 500 mg 83324-0221-66 QUALITY 66 tablets $0.017 — Availability likely —
Tums 500 mg 00135-0070-03 Haleon 36 tablets — — FDA listed —
Tums 500 mgthis 00135-0071-27 Haleon 150 tablets — — FDA listed —
Tums Regular Strength 500 mg 00135-0611-01 Haleon 150 tablets — — FDA listed —
Antacid Regular Strength 500 mg 00363-0317-34 WALGREEN 150 tablets — — FDA listed —
Antacid Regular strength 500 mg 00363-1224-12 WALGREEN 12 tablets — — FDA listed —
Antacid 500 mg 17714-0041-01 Advance 100 tablets — — FDA listed —
Antacid 500 mg 17714-0043-15 Advance 150 tablets — — FDA listed —
Regular Strength Antacid 500 mg 21130-0501-50 SAFEWAY 150 tablets — — FDA listed —
Topcare Antacid Calcium 500 mg 36800-0478-48 Topco 150 tablets — — FDA listed —
Topcare Antacid Calcium Regular Strength 500 mg 36800-0485-48 Topco 150 tablets — — FDA listed —
HEB Regular strength Assorted Fruit 500 mg 37808-0101-16 HEB 150 tablets — — FDA listed —
HEB Regular Strength Peppermint Flavor 500 mg 37808-0111-15 HEB 150 tablets — — FDA listed —
BI-MART Regular Strength Antacid Peppermint 500 mg 37835-0115-17 Bi-Mart 150 tablets — — FDA listed —
BI-MART Regular Strength Antacid 500 mg 37835-0126-17 Bi-Mart 150 tablets — — FDA listed —
EQUALINE regular strength antacid 500 mg 41163-0101-46 SUPERVALU 150 tablets — — FDA listed —
Equqline Regular Strength Antacid 500 mg 41163-0131-17 UNITED 150 tablets — — FDA listed —
EQUALINE Regular Strength Antacid Peppermint 500 mg 41163-0132-17 UNITED 150 tablets — — FDA listed —
Meijer Regular strength Assorted Fruit 500 mg 41250-0270-15 MEIJER 150 tablets — — FDA listed —
Meijer Regular Strength Peppermint Flavor 500 mg 41250-0965-15 MEIJER 150 tablets — — FDA listed —
Publix Regular Strength Assorted Fruit 500 mg 41415-0101-50 PUBLIX 150 tablets — — FDA listed —
Publix Regular Strength Peppermint Flavor 500 mg 41415-0111-50 PUBLIX 150 tablets — — FDA listed —
Regular Strength Antacid Peppermint 500 mg 42507-0151-17 Hyvee 150 tablets — — FDA listed —
Regular Strength Antacid Assorted Fruit Regular strength Antacid 500 mg 42507-0350-17 Hyvee 150 tablets — — FDA listed —
Whole Foods Market Regular Strength Peppermint Flavor 500 mg 42681-0028-01 WHOLE 12 tablets — — FDA listed —
Whole Foods Market Regular Strength Peppermint Flavor 500 mg 42681-0029-01 WHOLE 150 tablets — — FDA listed —
Xpect Antacid 500 mg 42961-0208-02 Cintas 2 tablets — — FDA listed —
Calcium Antacid 500 mg 48433-0106-01 Safecor 100 tablets — — FDA listed —
Regular Strength Antacid 500 mg 49035-0889-15 Wal-Mart 150 tablets — — FDA listed —
GoodSense Regular Strength Antacid 500 mg 50804-0112-17 GoodSense 150 tablets — — FDA listed —
Goodsense Regular Strength Antacid Peppermint 500 mg 50804-0113-17 GoodSense 150 tablets — — FDA listed —
Calcium Carbonate 500 mg 51376-0127-05 Blessings 500 tablets — — FDA listed —
Guardian Regular Strength Alkums 500 mg 53041-0098-17 Guardian 150 tablets — — FDA listed —
Alkums antacid 500 mg 53041-0126-17 Guardian 150 tablets — — FDA listed —
Regular Strength Peppermint Antacid 500 mg 53942-0113-17 DeMoulas 150 tablets — — FDA listed —
Regular Strength Antacid 500 mg 53942-0126-17 DeMoulas 150 tablets — — FDA listed —
Regular Strength Antacid Peppermint 500 mg 53943-0117-17 Discount 150 tablets — — FDA listed —
Regular Strength Antacid Regular strength Antacid 500 mg 53943-0126-17 Discount 150 tablets — — FDA listed —
Antacid 500 mg 54738-0030-15 Richmond 150 tablets — — FDA listed —
Calcium Carbonate 500 mg 55154-6751-00 Cardinal 1 tablet — — FDA listed —
Family Wellness Regular Strength Antacid 126 Regular strength Antacid 500 mg 55319-0921-17 Family 150 tablets — — FDA listed —
DG HEALTH Regular Strength 500 mg 55910-0049-50 DOLGENCORP, 150 tablets — — FDA listed —
DG Health Regular Strength Antacid 500 mg 55910-0510-50 DOLGENCORP, 150 tablets — — FDA listed —
Calcium Carbonate Chewable Antacid 500 mg 57896-0763-15 Geri-Care 150 tablets — — FDA listed —
Quality Choice Regular Strength Peppermint Flavor 500 mg 63868-0700-15 CHAIN 150 tablets — — FDA listed —
Quality Choice Antacid Assorted Fruit 500 mg 63868-0701-66 CHAIN 66 tablets — — FDA listed —
Best Choice Assorted Fruit 500 mg 63941-0010-50 BEST 150 tablets — — FDA listed —
Best Choice Regular Strength 500 mg 63941-0101-50 BEST 150 tablets — — FDA listed —
WinCo FOODS Antacid Regular strength 500 mg 67091-0356-15 WINCO 150 tablets — — FDA listed —
WinCo FOODS Antacid Regular Strength 500 mg 67091-0357-15 WINCO 150 tablets — — FDA listed —
Premier Value Chewable Antacid Assorted Fruit 500 mg 68016-0652-00 Chain 150 tablets — — FDA listed —
Premier Value Regular Strength Chewable Antacid Peppermint Assorted Fruit 500 mg 68016-0665-00 Chain 150 tablets — — FDA listed —
Premier Value Chewable Antacid Extra Strength Assorted Fruit 500 mg 68016-0666-00 Chain 150 tablets — — FDA listed —
Premier Value Chewable Antacid Extra Strength Tropical Fruit 500 mg 68016-0668-00 Chain 150 tablets — — FDA listed —
Premier Value Chewable Antacid Ultra Strength Assorted Fruit 500 mg 68016-0669-00 Chain 150 tablets — — FDA listed —
Premier Value Smooth Antacid Extra Strength Assorted Fruit 500 mg 68016-0675-00 Chain 90 tablets — — FDA listed —
Calcium Carbonate Assorted Flavors 500 mg 68071-2258-05 NuCare 150 tablets — — FDA listed —
Calcium Carbonate 500 mg 68071-2345-05 NuCare 150 tablets — — FDA listed —
Fast Acting Heartburn Relief Peppermint Flavor 500 mg 68163-0011-00 Raritan 100 tablets — — FDA listed —
Regular Strength Tropical Fruit 500 mg 68163-0100-66 RARITAN 66 tablets — — FDA listed —
DRx CHOICE Antacid Calcium Regular Strength 500 mg 68163-0101-12 Raritan 60 tablets — — FDA listed —
Regular strength Assorted Fruit 500 mg 68998-0101-50 MARC 150 tablets — — FDA listed —
Calcium Carbonate 500 mg 69168-0124-54 Allegiant 15000 tablets — — FDA listed —
Calcium Antacid 500 mg 69168-0219-02 Allegiant 150 tablets — — FDA listed —
Regular Strength Antacid Peppermint 500 mg 69256-0113-17 Harris 150 tablets — — FDA listed —
Regular Strength Antacid 500 mg 69256-0138-17 Harris 150 tablets — — FDA listed —
Calcium Carbonate 500 mg 69618-0020-15 Reliable 150 tablets — — FDA listed —
Regular Strength Assorted Flavors 500 mg 71399-9939-01 AKRON 150 tablets — — FDA listed —
Regular Strength Antacid Peppermint 500 mg 71399-9940-01 AKRON 150 tablets — — FDA listed —
Careone Regular Strength Calcium Antacid 500 mg 72476-0022-17 Retail 150 tablets — — FDA listed —
Careone Regular Strength calcium Antacid 500 mg 72476-0026-17 Retail 150 tablets — — FDA listed —
Citrus Flavored Antacid 500 mg 73598-1392-01 JHK 2 tablets — — FDA listed —
KOSHER MEDS antacid 500 mg 82179-0005-15 Mollec 150 tablets — — FDA listed —
MGC Health Calcium Carbonate Antacid Assorted Fruits 500 mg 83173-0135-60 Medical 60 tablets — — FDA listed —
MGC Health Calcium Carbonate Antacid Assorted Fruits 500 mg 83698-0135-60 Xiamen 60 tablets — — FDA listed —
Cherry Antacid 500 mg 84269-2517-01 Wildman 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

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 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 Pink / White
ShapeRound
ImprintTUMS
Size16 mm
ScoringNot scored
FlavorPeppermint
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 76A0JE0FKJ
    Adipic acid is an organic compound used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in the product to keep it stable and improve how the body absorbs the active ingredient.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII P1BM4ZH95L
    A salt derived from phosphoric acid, sodium polymetaphosphate acts as a sequestrant and buffering agent in medicines. It helps maintain stability and control acidity in liquid formulations.
  • 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.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statesAdipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

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

LabelerHaleon US Holdings LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedMar 2010
Product typeHuman Otc Drug
Portfolio405 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms

⏱️ Dosage and Administration 41 words ▾

Directions • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

⚠️ Warnings 77 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 15 tablets in 24 hours • if pregnant do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor Keep out of reach of children.

🧪 Active Ingredient 9 words ▾

Active ingredient (per tablet) Calcium Carbonate USP 500 mg

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients (assorted fruit) Adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredient (peppermint) corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

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 49 words ▾

When using this product • do not take more than 15 tablets in 24 hours • if pregnant do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 25 words ▾

Questions? 1-800-897-7535 weekdays Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free www.tums.com GlaxoSmithKline Moon Twp, PA 15108

📄 Package Label / Principal Display Panel 76 words ▾

PRINCIPAL DISPLAY PANEL NDC 0135-0071-27 TUMS ® CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Assorted Fruit 150 CHEWABLE TABLETS PAREVE ©2014 GSK Front Label: 103784XA Back Label: 103783XA Tums Regular Assorted Fruit 150 count label

Principal Display Panel NDC 0135-0070-27 TUMS ® CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Peppermint 150 CHEWABLE TABLETS PAREVE ©2014 GSK Front Label: 103781XA Back Label: 103780XA Tums Regular Peppermint 150 count label

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 TUMS (this brand).

Top reported reactions

Fatigue6,165
Nausea5,551
Diarrhoea4,839
Pain4,828
Dyspnoea4,710
Chronic Kidney Disease4,518
Vomiting4,428

Age at onset

Neonate87
Infant22
Child125
Adolescent167
Adult4,477
Elderly4,448

Reporter sex

62,714 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization27,060
Death8,789
Life-threatening6,293
Disabling5,209
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,519 0
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 Haleon US Holdings LLC. 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 12 tablets (00135-0071-48). 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?
Haleon US Holdings LLC 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.
← 00135-0070-03 · Haleon 00135-0074-01 · Haleon →
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.