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Sodium Bicarbonate 5 gr 325 mg Tablet, 200-count — NDC 55681-307-02 (Billing 55681-0307-02)

by TWIN MED LLC · 200 TABLET in 1 BOTTLE

This is a package of 200 tablets of Sodium Bicarbonate 5 gr 325 mg Tablet from TWIN MED LLC, marketed since Jun 2022 and currently FDA-listed, this package's marketing is listed to end Dec 2029. It is this product's only package size.

NDC 55681-0307-02
🏷️ FDA NDC (as labeled) 55681-307-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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 55681-307-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55681 labeler · 307 product · 02 package
Package marketed since
Jun 30, 2022
Package marketing ended
Dec 31, 2029
Sample package
No — commercial package
Barcode (UPC)
0816516013775
FDA record last changed
Aug 20, 2026
⚠️
Other active recalls for Sodium Bicarbonate (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 4, 2025 — Lack of Assurance of Sterility. (PFIZER INC) · FDA recall D-0591-2025
Class II · Jul 30, 2025 — Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. (Exela Pharma Sciences LLC) · FDA recall D-0620-2025
Class II · Mar 7, 2025 — Lack of Assurance of Sterility (Exela Pharma Sciences LLC) · FDA recall D-0303-2025
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0234-2024
Class I · Oct 18, 2023 — Presence of Particulate Matter: Silicone (Exela Pharma Sciences LLC) · FDA recall D-0116-2024
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) 55681-307-02
Product NDC 55681-307
11-digit billing NDC 55681030702
RxCUI 198859
UNII 8MDF5V39QO
UPC 0816516013775
Application # M001
SPL Set ID e325d899-d9a6-5adb-e053-2995a90ac861
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-30
Marketing end 2029-12-31
Route ORAL
Dosage form TABLET
Substance SODIUM BICARBONATE
Quick answers
  • RxCUI (RxNorm): 198859
Why two NDCs? The FDA registers this code as 55681-307-02 — 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 → 55681-0307-02. 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 Salt solutions class.

Drug family (ATC) Salt solutions, Electrolyte solutions
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

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. By mouth, it relieves heartburn, sour stomach and acid indigestion. On the skin, some products ease itching from insect bites and poison ivy. The injecti...
  • Labels for products like Rapidol and De La Cruz Sodium Bicarbonate Antacid say to dissolve it completely in water and drink it. It can be repeated every couple of hours up to a dai...
  • Don't use the maximum dose for more than 2 weeks unless a doctor tells you to. If your symptoms last longer than 2 weeks, stop and see your doctor.
  • Antacids can interact with some prescription drugs. Please check with me or your doctor before using it if you take any.
📖 Read our full Sodium Bicarbonate guide →
4
Nutrient depletion considerations

Sodium Bicarbonate (OTC Drug) may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sodium Bicarbonate (OTC Drug) 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.
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
55681-0307-02 You're viewing this Main listing 200 TABLET in 1 BOTTLE 2022-06-30 Dec 31, 2029 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Bicarbonate Antacid 325 mg 00536-1046-10 Rugby 1000 tablets $0.015 — Availability likely —
Sodium Bicarbonate Antacid 325 mg 54738-0035-03 Richmond 1000 tablets — — FDA listed —
Sodium Bicarbonate 5 gr 325 mg 55681-0072-02 TWIN 200 tablets — — FDA listed —
Sodium Bicarbonate 5 gr 325 mgthis 55681-0307-02 TWIN 200 tablets — — FDA listed —
Sodium Bicarbonate 5 gr (325 mg) 70369-0002-01 CitraGen 1000 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerTWIN MED LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code55681
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio48 products on file

More NDCs from TWIN MED LLC labeler code 55681

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 and Cautions ⚠️ Warnings 🔄 Drug Interactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

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

⏱️ Dosage and Administration 56 words ▾

Directions Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking. D0 NOT EXCEED RECOMMENDED DOSE Not recommended for children.

⚠️ Warnings and Cautions 42 words ▾

Stomach Warning TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK Consult a doctor if severe stomach pain occurs after taking this product.

⚠️ Warnings 185 words ▾

Warnings Do not use this product if you are on a sodium-restricted diet unless directed by a doctor Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product Drug Interaction Precaution Stomach Warning TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution Ask a physician or pharmacist before use if you are presently taking a prescription drug Antacids may interact with certain prescription drugs KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

🔄 Drug Interactions 28 words ▾

Drug Interaction Precaution

Drug Interaction Precaution Ask a physician or pharmacist before use if you are presently taking a prescription drug Antacids may interact with certain prescription drugs

🧪 Active Ingredient 11 words ▾

Active ingredient (in each tablet) Sodium bicarbonate 5 gr (325 mg)

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Pregelatinized starch, NF and mineral oil, USP

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Do Not Use 91 words ▾

Do not use this product if you are on a sodium-restricted diet unless directed by a doctor Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product Drug Interaction Precaution

📄 Keep Out of Reach of Children 26 words ▾

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

📄 Questions or Comments 6 words ▾

Questions or comments? call toll-free 1-844-912-4012

📄 Package Label / Principal Display Panel 17 words ▾

Distributed by: ProCure Products Santa Fe Springs, CA 90670 MADE IN THE USA ITEM# PCOTC102 sodium bicarb

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Bicarbonate (matched by generic name) — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Bicarbonate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$136.8K
Claims incl. refills
2.2K
Beneficiaries
722
Spend / beneficiary
$189.50
Spend / claim
$61.05
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Sodium Bicarbonate 5 gr (this brand).

Top reported reactions

Acute Kidney Injury1,696
Diarrhoea1,444
Renal Failure1,374
Nausea1,182
Anaemia1,111
Death1,061
Dyspnoea1,027

Age at onset

Neonate63
Infant40
Child117
Adolescent97
Adult2,173
Elderly1,835

Reporter sex

23,114 reports
Male · 53%
Female · 47%
Unknown · 0%

Serious outcomes

Hospitalization12,117
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,941 959
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 it is currently marketed — but TWIN MED LLC has reported a marketing end date of 2029-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
TWIN MED 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.
← 55681-0306-14 · Twin 55681-0311-03 · TWIN →
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.