puregen labs allergy relief

Generic: diphenhydramine hcl

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name puregen labs allergy relief
Generic Name diphenhydramine hcl
Labeler advanced rx llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-201
Product ID 80513-201_4745d501-fbad-b33f-e063-6294a90a0753
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 80513201
Hyphenated Format 80513-201

Supplemental Identifiers

RxCUI
1049906
UPC
0380513000552
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 puregen labs 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
  • 473 mL in 1 BOTTLE (80513-201-16)
source: ndc

Packages (1)

80513-201-16 473 mL in 1 BOTTLE (80513-201-16)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Puregen Labs Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4745d501-fbad-b33f-e063-6294a90a0753", "openfda": {"upc": ["0380513000552"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["4745d4f9-bbdf-a4a6-e063-6294a90a15b2"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (80513-201-16)", "package_ndc": "80513-201-16", "marketing_start_date": "20241201"}], "brand_name": "Puregen Labs Allergy Relief", "product_id": "80513-201_4745d501-fbad-b33f-e063-6294a90a0753", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "80513-201", "generic_name": "Diphenhydramine HCl", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Puregen Labs 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"}