diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0978
Product ID 0121-0978_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087513
Listing Expiration 2026-12-31
Marketing Start 1982-02-10

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210978
Hyphenated Format 0121-0978

Supplemental Identifiers

RxCUI
1049906
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number ANDA087513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10)
source: ndc

Packages (1)

0121-0978-00 10 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/10mL)

Linked Drug Pages (1)

DIPHENHYDRAMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b7eb09fa-58fb-4c3f-ad65-a04965bc52b0", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["6fe6fe2d-4405-4e7a-a2ed-5eb367d52842"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0978-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10)", "package_ndc": "0121-0978-00", "marketing_start_date": "19820210"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "0121-0978_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0121-0978", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "ANDA087513", "marketing_category": "ANDA", "marketing_start_date": "19820210", "listing_expiration_date": "20261231"}