Home NDC 71872-7373 Diphenhydramine Hydrochloride
Product NDC 71872-7373
11-digit product format 718727373
Labeler code 71872
Product ID 71872-7373_51bb1ca2-32ef-4840-e063-6394a90a6faa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC
Application ANDA205336
Marketing category ANDA
Marketing start 2025-06-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A205336-001 AP
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings 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 cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS The most frequent adverse reactions are italicized. General Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. 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. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.
Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii TC2D6JAD40 Rxcui 1723740
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71872-7373-1 Diphenhydramine Hydrochloride 1 in 1 BAG INJECTION 1 1 71872-7373-1 Diphenhydramine Hydrochloride 1 mL in 1 VIAL, GLASS INJECTION 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71872-7373-1 71872737301 1 VIAL, GLASS in 1 BAG (71872-7373-1) / 1 mL in 1 VIAL, GLASS 2026-05-13 No No Current