Puregen Labs Allergy Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Puregen Labs Allergy Relief
Generic name: DIPHENHYDRAMINE HCL
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4745d4f9-bbdf-a4a6-e063-6294a90a15b2
SPL ID: 4745d501-fbad-b33f-e063-6294a90a0753
Version: 1
Effective date: 2025-12-31
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:11:16

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Puregen Labs Allergy Relief	openfda.brand_name
generic name		DIPHENHYDRAMINE HCL	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-201-16	openfda.package_ndc
ndc	product	80513-201	openfda.product_ndc
ndc11	package	80513020116	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		4745d501-fbad-b33f-e063-6294a90a0753	id
spl set id		4745d4f9-bbdf-a4a6-e063-6294a90a15b2	set_id
unii		TC2D6JAD40	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use with any other product conatining diphenhydramine, including one used on the skin to make a child sleepy Ask a doctor before use if you have a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur sedatives, and tranquilizers may increase drowsiness

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.