diphenhydramine hcl

Generic: diphenhydramine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0865
Product ID 0121-0865_d56f4fe1-e90c-4e35-a488-12c93938a3dd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-18

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 01210865
Hyphenated Format 0121-0865

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 hcl (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)
  • 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)
source: ndc

Packages (2)

0121-0865-00 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) 0121-0865-30 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d56f4fe1-e90c-4e35-a488-12c93938a3dd", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["3c3e0dc8-cddd-4f46-9b68-19bac00c07cc"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0865-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)", "package_ndc": "0121-0865-00", "marketing_start_date": "20200618"}, {"sample": false, "description": "3 TRAY in 1 CASE (0121-0865-30)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)", "package_ndc": "0121-0865-30", "marketing_start_date": "20200618"}], "brand_name": "Diphenhydramine HCl", "product_id": "0121-0865_d56f4fe1-e90c-4e35-a488-12c93938a3dd", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0121-0865", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200618", "listing_expiration_date": "20261231"}