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OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonate 1 g/g; 1 g/g Powder — NDC 49631-0178-21 package photo

OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonate 1 g/g; 1 g/g Powder

by OHTA'S ISAN CO.,LTD. · 1 CAN in 1 BOX (49631-178-21) / 75 g in 1 CAN
NDC 49631-0178-21
🏷️ FDA NDC (as labeled) 49631-178-21 billing pads the product segment with a zero
This package
Contains75 g in 1 can Pack sizes3 compare ↓
Also comes in: 140 g 49631-0178-22 1.3 g 49631-0178-13
OTC On market Non-controlled
🗂️ Data synced Sep 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) 49631-178-21
Product NDC 49631-178
11-digit billing NDC 49631017821
RxCUI 1361708
UNII H0G9379FGK, 8MDF5V39QO
Application # M001
SPL Set ID 53380470-5748-6fa7-548e-7484ef204c0f
Mechanism of action Alkalinizing Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-01
Route ORAL
Dosage form POWDER
Substance CALCIUM CARBONATE; SODIUM BICARBONATE
Why two NDCs? The FDA registers this code as 49631-178-21 — 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 → 49631-0178-21. 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

LabelerOHTA'S ISAN CO.,LTD.
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code49631
First marketedJul 2017
Product typeHuman Otc Drug
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

📖 About the active ingredient: Calcium Carbonate; Sodium Bicarbonate MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

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 ↗
🧪 What is this product?

This is an over-the-counter antacid powder taken by mouth that contains calcium carbonate and sodium bicarbonate as active ingredients. Both of these substances are commonly used to neutralize stomach acid and are typically included in products meant to relieve heartburn, acid indigestion, and upset stomach. This product is marketed under the FDA's OTC monograph rules for antacids rather than as an individually reviewed drug application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 5S29HWU6QB
    Cinnamon is a spice derived from tree bark. It's used in medicines as a flavoring agent to improve taste and mask unpleasant flavors, making the medicine easier to take.
  • UNII K48IKT5321
    A plant extract from clove buds used as a flavoring agent and natural fragrance in medications. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII 557II4LLC3
    Fennel is a plant seed with a licorice-like flavor. It's used in medicines as a flavoring agent to improve taste and make the product more pleasant to take.
  • UNII S72O3284MS
    A plant extract from the gentian root used as a flavoring agent and bitter taste component in some medicines. It helps mask unpleasant tastes and may support digestive formulations.
  • UNII BZ1R15MTK7
    Levomenthol is the left-handed form of menthol, a natural cooling compound from mint plants. It's used in medicines as a flavoring agent and to provide a cooling sensation on the skin or mucous membranes.
  • UNII 0E53J927NA
    Magnesium carbonate is a mineral powder used in medicines as a filler to add bulk and as a buffer to help regulate acidity in the formulation.
  • UNII AEE24M3MQ9
    Nutmeg is a natural spice derived from the seed of the nutmeg tree. It's used in medicines as a flavor ingredient to improve taste and mask unpleasant flavors in oral formulations.
  • UNII 75EIV4LX7W
    A natural extract from tropical quassia wood, used as a flavoring agent and bitter taste component in some medications to mask other flavors or add taste characteristics to the formulation.
  • UNII KH3E3096OO
    A natural flavoring derived from tangerine fruit. It adds taste and aroma to make medicines more pleasant to take, especially in chewable tablets or liquids.

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

The official label also statescinnamon bark, citrus unshiu peel, clove, fennel, gentian,  l -menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

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 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.
Try another pack size: 140 g 1.3 g
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
Ohtas Isan Antacid 1 g/g; 1 g/gthis 49631-0178-21 OHTA'S 1 can — — 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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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
49631-0178-21 You're viewing this 1 CAN in 1 BOX (49631-178-21) / 75 g in 1 CAN 2000-10-16 Active
49631-0178-22 1 CAN in 1 BOX (49631-178-22) / 140 g in 1 CAN 2000-10-16 Active
49631-0178-13 1 DOSE PACK in 1 BOX (49631-178-13) / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET 2017-07-01 Active

Pack size FAQ

What quantity is in NDC 49631-0178-21?
NDC 49631-0178-21 is listed by the FDA — 1 can in 1 box / 75 g in 1 can.
What NDC number is used to bill for this package of OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonate 1 g/g; 1 g/g Powder?
Bill NDC 49631-0178-21 — the 11-digit billing format is 49631017821. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 49631-178-21, 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: 49631-0178-21, written without dashes as 49631017821. 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 49631-0178-21, the first segment (49631) is the labeler code FDA assigned to OHTA'S ISAN CO.,LTD.; the middle segment (0178) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) 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 OHTA'S ISAN CO.,LTD.. 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 2 other package presentations of this same product, including 1 can (49631-0178-22), 1 dose (49631-0178-13). 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?
OHTA'S ISAN 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

Uses relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms

⏱️ Dosage and Administration 16 words ▾

Direction take 1 spoonful (using the spoon included with this can) with water, 3 times daily.

⚠️ Warnings 34 words ▾

Warnings Do not use more than 3 spoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

📦 Storage and Handling 8 words ▾

Other Information each spoonful contains: sodium 164 mg.

🧪 Active Ingredient 14 words ▾

Active Ingredients (in each spoonful) Precipitated calcium carbonate 497 mg Sodium bicarbonate 600 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients cinnamon bark, citrus unshiu peel, clove, fennel, gentian, l -menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

🎯 Purpose 10 words ▾

Purpose Precipitated calcium carbonate ............. Antacid Sodium bicarbonate ............................. Antacid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49629-0046-99 · Rottendorf 49632-0070-05 · PMC →
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.