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Prescription and over-the-counter medicine

Ascorbic acid Brand names: Ascor

Ascorbic acid (Ascor) is a prescription and over-the-counter medicine with an FDA approval on record since 2017. FDA's NDC Directory lists it from 4 generic labelers.

  • Generic listed

Check it at the source: the ascorbic acid FDA label on DailyMed (effective May 29, 2026, McGuff Pharmaceuticals, Inc.); the NDA 209112 record on Drugs@FDA; every ascorbic acid label on DailyMed.

Highlights of the record

FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Forms and strengths

  • 500 mg/ml

Injection.

On the market

Earliest approval on file
October 2, 2017 Ascor, Mcguff; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
3 first August 7, 2025; 3 with a marketed status in Drugs@FDA
Labelers listed (NDC)
5 of which 4 under generic applications, 1 under brand applications, repackagers included; 2 more under the over-the-counter monograph, without an application

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
4 since 2012 2 Class I among all firms' recalls; latest July 30, 2025; 36 more by firms not listed as its makers
FAERS reports
23,122 through July 30, 2026

What is ascorbic acid used for?

From the label: indications and usage

INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. […]

FDA pharmacologic class: Vitamin C.

Source: FDA drug label (Ascor), McGuff Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 388aad52-fc01-4784-9791-1dbc80c69306), via openFDA; the full label on DailyMed

Is there a generic for ascorbic acid (Ascor)?

The FDA approved the first generic ascorbic acid on August 7, 2025. 3 generic applications are approved; 3 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 ascorbic acid from 4 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.

  • 2017 earliest approval on file
  • 2025 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has ascorbic acid been recalled?

The FDA's Enforcement Report lists 40 recalls naming ascorbic acid since 2012: 2 Class I (the most serious), 38 Class II, 0 Class III; 4 still ongoing. 36 of them are by firms that FDA's NDC Directory does not list as a maker of ascorbic acid 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.

StartedClassCompanyReason
July 30, 2025Class IIGenoGenix LLCLack of Assurance of Sterility
March 7, 2022Class IITMC Acquisition LLC dba Tailor Made Compounding not a listed makerLack of Assurance of Sterility
November 17, 2021Class IIASP CARES not a listed makerLack of Assurance of Sterility
August 13, 2021Class IIFirst Royal Care Co. LLC, dba Red Mountain Compounding … not a listed makerLack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
September 12, 2019Class IIKRS Global Biotechnology, Inc not a listed makerLack of Assurance of Sterility
August 28, 2019Class IIAtlas Pharmaceuticals, LLC not a listed makerLabeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
June 19, 2019Class IIRXQ Compounding LLC not a listed makerCrystallization
December 17, 2018Class IIPromise Pharmacy, LLC not a listed makerLack of sterility assurance.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the ascorbic acid label say about other medicines?

The ascorbic acid label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name ascorbic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Amphetaminedrug interactionsBleomycin is inactivated ​in vitro ​by ascorbic acid (7.1). ​Amphetamine and Other Drugs Affected by Urine Acidification:​ Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH (7.2). …
Bleomycindrug interactionsBleomycin is inactivated ​in vitro ​by ascorbic acid (7.1). ​Amphetamine and Other Drugs Affected by Urine Acidification:​ Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH (7.2). …
Cysteinewarnings and precautionsAcidification of the urine by ascorbic acid may cause precipitation of cysteine, urate or oxalate stones.
Doxycyclinedrug interactionsDRUG INTERACTIONS ​Antibiotics:​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Erythromycindrug interactionsDRUG INTERACTIONS ​Antibiotics:​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Fluphenazinedrug interactionsIt has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations.
Lincomycindrug interactionsDRUG INTERACTIONS ​Antibiotics:​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Streptomycindrug interactionsDRUG INTERACTIONS ​Antibiotics:​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Warfarindrug interactions… amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH (7.2). ​Warfarin:​ Continue standard monitoring (7.3) ​ See 17 for PATIENT COUNSELING INFORMATION ​Antibiotics: ​ Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and …

Other labels that name ascorbic acid

Check ascorbic acid against other medicines

Source: FDA drug label (Ascor), McGuff Pharmaceuticals, Inc., effective May 29, 2026 (SPL set 388aad52-fc01-4784-9791-1dbc80c69306), via openFDA; the full label on DailyMed

What do FAERS reports show for ascorbic acid?

The FDA Adverse Event Reporting System holds 23,122 reports that list ascorbic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,611 are coded as a death and 9,238 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

  • Fatigue2,337
  • Pain2,101
  • Nausea (named in the label)1,999
  • Diarrhoea1,829
  • Headache (named in the label)1,807
  • Drug Ineffective (a use or a product term, not a reaction)1,774
  • Dyspnoea1,690
  • Vomiting1,566

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other vitamin cs
the pharmacologic class, with prices and generics
Ascorbic acid side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other