Prescription and over-the-counter medicine
Diphenhydramine First approved as Benadryl
Diphenhydramine (Benadryl) is a prescription and over-the-counter medicine with an FDA approval on record since 1946. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.898 per mL (Diphenhydramine 50 mg/mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the diphenhydramine FDA label on DailyMed (effective November 18, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 5845 record on Drugs@FDA; every diphenhydramine label on DailyMed.
Highlights of the record
FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDiphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical.
Forms and strengths
- 12.5 mg/5ml
- 25 mg/10ml
- 50 mg/ml
Injection; injection (solution); solution.
On the market
- Earliest approval on file
- March 4, 1946 Benadryl, Mcneil Cons; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 53 first May 9, 1972; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 20 under generic applications, 0 under brand applications, repackagers included; 209 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.898 per mL Diphenhydramine 50 mg/mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest December 12, 2024; 11 more by firms not listed as its makers
- FAERS reports
- 164,832 through July 30, 2026
What is diphenhydramine used for?
From the label: indications and usageDiphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness For active treatment of motion sickness. […]
Conditions named in the indications of diphenhydramine's FDA labels, with every medicine labeled for each:
From other diphenhydramine labelsCough and cold: temporarily relieves these symptoms of the common cold:
Allergies: Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes
Pain: For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Diphenhydramine Hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective November 18, 2025 (SPL set 6178d3a1-0741-49a4-be81-c4f7d29f8b2a), via openFDA; the full label on DailyMed
Is there a generic for diphenhydramine (Benadryl)?
The FDA approved the first generic diphenhydramine on May 9, 1972. 53 generic applications are approved; 10 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 diphenhydramine from 20 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1946 earliest approval on file
- 1972 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 diphenhydramine (Benadryl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.898 per mL (Diphenhydramine 50 mg/mL vial), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Diphenhydramine 50 mg/mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aller-g-time 25 mg caplet | Generic | $0.037 per unit | n/a | +3% |
| Allergy (diphen) 25 mg capsule | Generic | $0.0534 per capsule | $1.60 | n/a |
| Allergy (diphen) 25 mg minitab | Generic | $0.037 per unit | n/a | +3% |
| Allergy 25 mg tablet | Generic | $0.037 per tablet | $1.11 | +3% |
| Allergy relief 12.5 mg/5 mL | Generic | $0.0174 per mL | n/a | +37% |
| Allergy relief 25 mg capsule | Generic | $0.0534 per capsule | $1.60 | +1% |
| Allergy relief 25 mg softgel | Generic | $0.0534 per unit | n/a | +1% |
| Allergy relief 25 mg tablet | Generic | $0.037 per tablet | $1.11 | +3% |
| Banophen 25 mg capsule | Generic | $0.0534 per capsule | $1.60 | +1% |
| Banophen 25 mg tablet | Generic | $0.037 per tablet | $1.11 | +3% |
| Banophen 50 mg capsule | Generic | $0.0298 per capsule | $0.893 | +20% |
| Child allergy rlf 12.5 mg/5 mL | Generic | $0.0185 per mL | n/a | +3% |
| Chld allrgy rlf 12.5 mg chewable tablet | Generic | $0.113 per tablet | $3.39 | no change |
| Dimetane 25 mg softgel | Generic | $0.0534 per unit | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has diphenhydramine been recalled?
The FDA's Enforcement Report lists 19 recalls naming diphenhydramine since 2012: 0 Class I (the most serious), 15 Class II, 4 Class III; 4 still ongoing. 11 of them are by firms that FDA's NDC Directory does not list as a maker of diphenhydramine 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 |
|---|---|---|---|
| December 12, 2024 | Class III | Akron Pharma, Inc. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. |
| April 28, 2023 | Class II | Central Admixture Pharmacy Services, Inc. not a listed maker | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| June 7, 2022 | Class II | Plastikon Healthcare LLC | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 10, 2019 | Class II | LNK International, Inc. not a listed maker | Microbial contamination of non-sterile product |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diphenhydramine label say about other medicines?
The diphenhydramine label names no other medicine on this site. The labels of 19 other medicines name diphenhydramine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name diphenhydramine
Source: FDA drug label (Diphenhydramine Hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective November 18, 2025 (SPL set 6178d3a1-0741-49a4-be81-c4f7d29f8b2a), via openFDA; the full label on DailyMed
What do FAERS reports show for diphenhydramine?
The FDA Adverse Event Reporting System holds 164,832 reports that list diphenhydramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22,785 are coded as a death and 47,567 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 diphenhydramine?
27 other medicines are given the same way (oral) and in the same FDA class as diphenhydramine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 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 |
|---|---|---|---|---|
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 mg tablet | No current entry |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 mg tablet | No current entry |
| Fexofenadine and pseudoephedrine | Cough and cold | 27 labelers | $0.483 per tablet 60-120 tablet | No current entry |
| Chlorpheniramine | Allergies | 2 labelers | $0.0177 per tablet 4 mg tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
| Carbinoxamine | Allergies | 7 labelers | $0.398 per tablet 4 mg tablet | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Allergies, Cough and cold | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as diphenhydramine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does diphenhydramine compare with medicines for the same use?
12 side-by-side pages set diphenhydramine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to diphenhydramine
- 27 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Diphenhydramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other