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Diphenhydramine Hydrochloride 50 mg/mL Injection, Solution — NDC 76045-0102-10 package photo

Diphenhydramine Hydrochloride 50 mg/mL Injection, Solution

by Fresenius Kabi USA, LLC · 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
NDC 76045-0102-10
🏷️ FDA NDC (as labeled) 76045-102-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 76045-102-10
Product NDC 76045-102
11-digit billing NDC 76045010210
NCPDP billing unit ML — per mL (volume)
RxCUI 1049289
UNII TC2D6JAD40
Application # ANDA091526
SPL Set ID 6d1aa0e2-036d-4382-a458-fc0300dba7cb
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-26
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 41200030102010
GPI class diphenhydrAMINE HCl
GCN Seq No 011585
GCN 46000
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name DIPHENHYDRAMINE 50 MG/ML SYRNG
FDB brand name Diphenhydramine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 76045-102-10 — 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 → 76045-0102-10. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA091526 (ANDA)
Labeler code76045
First marketedMar 2013
Product typeHuman Prescription Drug
Portfolio554 products on file
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.

🩺 Clinical

Label name DIPHENHYDRAMINE 50 MG/ML SYRNG Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The injectable form is used when taking a pill or liquid by mouth just isn't practical — for example, if you're having a serious allergic reaction, recovering from a procedure, or...
  • Why am I getting diphenhydramine as a shot instead of a pill?
  • Yes, drowsiness is one of the most common effects of diphenhydramine — it's a strong sedating antihistamine. You may also feel dizzy or have trouble coordinating your movements. Yo...
  • Will this injection make me very drowsy?
📖 Read our full Diphenhydramine Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $18.46 $442.99 / 24 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1200 $0.752 / J1200 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)76045-102-10
11-digit billing NDC76045-0102-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1200
DescriptorInjection, diphenhydramine hcl, up to 50 mg
Billing units / pkg24 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenhydramine Hydrochloride 50 mg/mL 23155-0263-31 Heritage 1 vial $0.790 AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 72485-0101-25 Armas 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 25021-0481-01 Sagent 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 00641-0376-25 Hikma 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mL 63323-0664-01 Fresenius 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mL 83634-0781-01 Avenacy, 25 vials $0.934 AP Availability likely —
Diphenhydramine hydrochloride 50 mg/mL 00641-6282-25 Hikma 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 23155-0264-41 Heritage 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mL 42571-0337-87 Micro 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mLthis 76045-0102-10 Fresenius 1 syringe — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 76045-0235-10 Fresenius 1 syringe — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1348-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7005-01 Medical 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7180-01 Medical 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 55154-5102-05 Cardinal 5 vials — AP FDA listed —
Diphenhydramine 50 mg/mL 65219-0820-01 Fresenius 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 84549-0101-25 ProPharma 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1219-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 70518-1082-01 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 55154-9363-05 Cardinal 5 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 70518-4536-00 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 00404-9851-01 Henry 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7373-01 Medical 1 vial — AP FDA listed —
Diphenhydramine hydrochloride 50 mg/mL 70518-4455-00 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine 50 mg/mL 42571-0169-55 Micro 10 ampules — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 42571-0511-56 Micro 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1374-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 68083-0611-25 Gland 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 85766-0253-25 Sportpharm 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2013
On the market since
Mar 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 76045-0102-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.5K
Units reimbursed last 4 qtrs
17.5K
Gross reimbursed last 4 qtrs
$322.7K
Avg / prescription
$92.75
Avg / unit
$18.4583
Latest quarter Q4 2025
704Rx
Fee-for-service vs managed care ⓘ
19% FFS 81% MCO
Fee-for-service · 650 Rx Managed care · 2,829 Rx
State Medicaid map
Alaska: no data reported AK Maine: 59 units · 4.2 per 100k residents ME Washington: 26 units · 0.3 per 100k residents WA Idaho: 939 units · 47.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 481 units · 8.4 per 100k residents MN Wisconsin: 5,206 units · 88.1 per 100k residents WI Michigan: no data reported MI New York: 691 units · 3.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 14 units · 1.5 per 100k residents SD Iowa: 17 units · 0.5 per 100k residents IA Illinois: 93 units · 0.7 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 2,451 units · 18.9 per 100k residents PA New Jersey: 75 units · 0.8 per 100k residents NJ Massachusetts: 826 units · 11.8 per 100k residents MA California: 550 units · 1.4 per 100k residents CA Utah: no data reported UT Colorado: 1,430 units · 24.3 per 100k residents CO Nebraska: 149 units · 7.5 per 100k residents NE Missouri: no data reported MO Kentucky: 20 units · 0.4 per 100k residents KY West Virginia: 68 units · 3.8 per 100k residents WV Virginia: 16 units · 0.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 30 units · 1.0 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,484 units · 13.7 per 100k residents NC South Carolina: 2,316 units · 43.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 366 units · 3.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 175 units · 0.8 per 100k residents FL
Units reimbursed · per 100k residents
0.288.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 88.1 /100k
2 Idaho 47.8 /100k
3 South Carolina 43.1 /100k
4 Colorado 24.3 /100k
5 Pennsylvania 18.9 /100k
6 North Carolina 13.7 /100k
7 Massachusetts 11.8 /100k
8 Minnesota 8.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 DIPHENHYDRAMINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,771 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76045-0102-10 You're viewing this 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 2013-03-26 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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

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 FDA registers it as 76045-102-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76045-0102-10, written without dashes as 76045010210. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76045-0102-10, the first segment (76045) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0102) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1200 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 135 words ▾

INDICATIONS AND USAGE Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in 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. Antiparkinsonism: For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

⏱️ Dosage and Administration 128 words ▾

DOSAGE AND ADMINISTRATION THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Pediatric Patients, other than premature infants and neonates: 5 mg/kg/24 hr or 150 mg/m 2 /24 hr. Maximum daily dosage is 300 mg.

Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly. Adults: 10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.

⛔ Contraindications 87 words ▾

CONTRAINDICATIONS Use in Neonates or Premature Infants: This drug should not be used in neonates or premature infants. Use in Nursing Mothers: Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic: Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

⚠️ Warnings 100 words ▾

WARNINGS Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine. Use in Pediatric Patients: In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

🤒 Adverse Reactions 107 words ▾

ADVERSE REACTIONS The most frequent adverse reactions are underscored: 1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. 2.

Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles. 3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. 5.

GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. 6. GU System: Urinary frequency, difficult urination, urinary retention, early menses.

7. Respiratory System: Thickening of bronchial secretions , tightness of chest or throat and wheezing, nasal stuffiness.

🔄 Drug Interactions 28 words ▾

Drug Interactions: Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

🤰 Pregnancy 72 words ▾

Pregnancy: Pregnancy Category B: Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 46 words ▾

Pediatric Use: Diphenhydramine should not be used in neonates and premature infants (see CONTRAINDICATIONS ). Diphenhydramine may diminish mental alertness, or in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE ). See also DOSAGE AND ADMINISTRATION section.

🆘 Overdosage 48 words ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms; dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. Stimulants should not be used. Vasopressors may be used to treat hypotension.

🧬 Clinical Pharmacology 81 words ▾

CLINICAL PHARMACOLOGY Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride in the injectable form has a rapid onset of action.

Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: Product Code Unit of Sale Strength Each RF787210 NDC 76045-235-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-235-01 1 mL Prefilled Single-Use Syringe This Product Contains an RFID. 787210 NDC 76045-102-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-102-00 1 mL Prefilled Single-Use Syringe Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from freezing and light.

Retain in carton until time of use. Do not place syringe on a sterile field.

📋 Description 106 words ▾

DESCRIPTION Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2 (Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a white, crystalline powder, is freely soluble in water and alcohol and has a molecular weight of 291.82. The molecular formula is C 17 H 21 NO·HCl and the structural formula is as follows: Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution.

Each mL contains a concentration of 50 mg of diphenhydramine hydrochloride and water for injection, for intramuscular or intravenous use. The solution for parenteral use has been adjusted to a pH between 4 and 6.5 with either sodium hydroxide or hydrochloric acid. Structural Formula

💬 Information for Patients 44 words ▾

Information for Patients: Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

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