Prescription and over-the-counter medicine
Sodium bicarbonate
Sodium bicarbonate is a prescription and over-the-counter medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.154 per mL (Sodium bicarbonate 8.4% vial) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the sodium bicarbonate FDA label on DailyMed (effective August 4, 2026); the NDA 19443 record on Drugs@FDA; every sodium bicarbonate label on DailyMed.
Highlights of the record
FDA label of August 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRelieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Forms and strengths
- 12.6 mg/ml
- 42 mg/ml
- 75 mg/ml
- 84 mg/ml
Injection (solution); injection; solution.
On the market
- Earliest approval on file
- June 3, 1986 Sodium Bicarbonate In Plastic Container, Abbott; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first November 9, 2005; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 22 under generic applications, 2 under brand applications, repackagers included; 33 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per mL Sodium bicarbonate 8.4% vial
- Shortage (FDA)
- 4 of 15 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 18 since 2013 8 Class I among all firms' recalls; latest August 4, 2025; 5 more by firms not listed as its makers
- FAERS reports
- 23,124 through July 30, 2026
What is sodium bicarbonate used for?
From the label: indications and usageRelieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Conditions named in the indications of sodium bicarbonate's FDA labels, with every medicine labeled for each:
From other sodium bicarbonate labelsAcid reflux and ulcers: Uses Relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Diarrhea: Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (Sodium Bicarbonate 5 gr), TWIN MED LLC, effective August 4, 2026 (SPL set e325d899-d9a6-5adb-e053-2995a90ac861), via openFDA; the full label on DailyMed
Is there a generic for sodium bicarbonate?
The FDA approved the first generic sodium bicarbonate on November 9, 2005. 16 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium bicarbonate from 22 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 2005 first generic approved
- 2017 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sodium bicarbonate?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per mL (Sodium bicarbonate 8.4% vial), down 6% from $0.164 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sodium bicarbonate 8.4% vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sodium bicarb 325 mg tablet | Generic | $0.0147 per tablet | $0.440 | +4% |
| Sodium bicarb 650 mg tablet | Generic | $0.0128 per tablet | $0.384 | +0.1% |
| Sodium bicarbonate 8.4% vial | Generic | $0.154 per mL | n/a | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is sodium bicarbonate in shortage?
The FDA Drug Shortage Database lists 4 of 15 sodium bicarbonate presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on March 1, 2017. 7 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-02) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4) | Exela Pharma Sciences, LLC | Current | October 1, 2026 |
| Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 63323-083-05) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-14) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-35) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5) | Exela Pharma Sciences, LLC | Current | October 1, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4) | Exela Pharma Sciences, LLC | Current | October 1, 2026 |
Every sodium bicarbonate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has sodium bicarbonate been recalled?
The FDA's Enforcement Report lists 23 recalls naming sodium bicarbonate since 2013: 8 Class I (the most serious), 15 Class II, 0 Class III; 6 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of sodium bicarbonate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 4, 2025 | Class II | PFIZER INC | Lack of Assurance of Sterility. |
| July 30, 2025 | Class II | Exela Pharma Sciences LLC | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. |
| March 7, 2025 | Class II | Exela Pharma Sciences LLC | Lack of Assurance of Sterility |
| December 21, 2023 | Class I | Pfizer Inc. | Presence of Particulate Matter; identified as glass |
| October 18, 2023 | Class I | Exela Pharma Sciences LLC | Presence of Particulate Matter: Silicone |
| November 28, 2022 | Class I | Exela Pharma Sciences LLC | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. |
| October 4, 2022 | Class I | Exela Pharma Sciences LLC | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sodium bicarbonate label say about other medicines?
The sodium bicarbonate label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name sodium bicarbonate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Hyaluronidase | warnings and precautions (prescription label) | Extravasation: Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site. |
| Lidocaine | warnings and precautions (prescription label) | Extravasation: Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site. |
Other labels that name sodium bicarbonate
Source: FDA drug label (Sodium Bicarbonate 5 gr), TWIN MED LLC, effective August 4, 2026 (SPL set e325d899-d9a6-5adb-e053-2995a90ac861), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium bicarbonate?
The FDA Adverse Event Reporting System holds 23,124 reports that list sodium bicarbonate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,268 are coded as a death and 12,122 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sodium bicarbonate?
20 other medicines are given the same way (oral) and in the same FDA class as sodium bicarbonate or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Calcium carbonate and famotidine and magnesium hydroxide | Acid reflux and ulcers | 20 labelers | $0.258 per tablet Acid reducer complete tablet chewable | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Famotidine | Acid reflux and ulcers | 144 labelers | $0.0289 per tablet 20 mg tablet | No current entry |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Sucralfate | Acid reflux and ulcers | 43 labelers | $0.173 per tablet 1 g tablet | No current entry |
Every medicine labeled for the same conditions as sodium bicarbonate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sodium bicarbonate compare with medicines for the same use?
1 side-by-side page set sodium bicarbonate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sodium bicarbonate
- 20 medicines for the same use
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Sodium bicarbonate side effects
- the label's list beside FAERS reports
- Sodium bicarbonate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other