allergy relief

Generic: diphenhydramine hcl

Labeler: llorens pharmaceuticals international division
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name diphenhydramine hcl
Labeler llorens pharmaceuticals international division
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Identifiers & Regulatory

Product NDC 54859-837
Product ID 54859-837_4745dfbc-e512-5953-e063-6394a90a3b26
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 54859837
Hyphenated Format 54859-837

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

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (54859-837-04)
source: ndc

Packages (1)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4745dfbc-e512-5953-e063-6394a90a3b26", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["2a46ea9b-29e9-5197-e063-6394a90abc73"], "manufacturer_name": ["LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (54859-837-04)", "package_ndc": "54859-837-04", "marketing_start_date": "20241201"}], "brand_name": "Allergy Relief", "product_id": "54859-837_4745dfbc-e512-5953-e063-6394a90a3b26", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "54859-837", "generic_name": "Diphenhydramine HCl", "labeler_name": "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}