Prescription and over-the-counter medicine
Caffeine First approved as Cafcit
Caffeine (Cafcit) is a prescription and over-the-counter medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.083 per alert aid 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the caffeine FDA label on DailyMed (effective July 29, 2026, Sagent Pharmaceuticals); the NDA 20793 record on Drugs@FDA; every caffeine label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCaffeine citrate is indicated for the treatment of apnea of prematurity.
Forms and strengths
- 20 mg/ml
- 60 mg/3ml
Solution; injection (solution); injection.
On the market
- Earliest approval on file
- September 21, 1999 Cafcit, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first September 21, 2006; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included; 39 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.083 per tablet Alert aid 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest July 2, 2013; 2 more by firms not listed as its makers
- FAERS reports
- 2,261 through July 30, 2026
What is caffeine used for?
From the label: indications and usageCaffeine citrate is indicated for the treatment of apnea of prematurity.
FDA pharmacologic class: Central Nervous System Stimulant and Methylxanthine.
Source: FDA drug label (caffeine citrate), Sagent Pharmaceuticals, effective July 29, 2026 (SPL set 5f38c395-0093-4afd-89ec-f96e5dc0934a), via openFDA; the full label on DailyMed
Is there a generic for caffeine (Cafcit)?
The FDA approved the first generic caffeine on September 21, 2006. 13 generic applications are approved; 9 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 caffeine from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2006 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for caffeine (Cafcit)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.083 per Alert aid 200 mg tablet, up 2% from $0.0817 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.
- Alert aid 200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alert aid 200 mg tablet | Generic | $0.083 per tablet | $2.49 | +2% |
| Caffeine 200 mg tablet | Generic | $0.083 per tablet | $2.49 | +2% |
| Ft stay awake 200 mg tablet | Generic | $0.083 per tablet | $2.49 | +2% |
| Qc stay awake 200 mg tablet | Generic | $0.083 per tablet | $2.49 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has caffeine been recalled?
The FDA's Enforcement Report lists 3 recalls naming caffeine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of caffeine 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 |
|---|---|---|---|
| May 22, 2017 | Class II | Global Marketing Enterprises, Inc. not a listed maker | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. … |
| October 6, 2015 | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: all sterile compounded products within expiry |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the caffeine label say about other medicines?
The caffeine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name caffeine. 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 |
|---|---|---|
| Cimetidine | drug interactions | Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and … |
| Ketoconazole | drug interactions | Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and … |
| Ketoprofen | drug interactions | Caffeine administered concurrently with ketoprofen reduced the urine volume in 4 four healthy volunteers. |
| Phenobarbital | drug interactions | … caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin). |
| Phenytoin | drug interactions | … be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin). |
| Theophylline | drug interactions | Interconversion between caffeine and theophylline has been reported in preterm neonates. |
Other labels that name caffeine
Source: FDA drug label (caffeine citrate), Sagent Pharmaceuticals, effective July 29, 2026 (SPL set 5f38c395-0093-4afd-89ec-f96e5dc0934a), via openFDA; the full label on DailyMed
What do FAERS reports show for caffeine?
The FDA Adverse Event Reporting System holds 2,261 reports that list caffeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,172 are coded as a death and 1,094 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 next?
- Other stimulants
- the pharmacologic class, with prices and generics
- Caffeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other