Bite and Itch

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: Bite and Itch
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE
Manufacturer: Weeks & Leo Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 0a4d471b-c3f3-0a6a-e063-6394a90ad57b
SPL ID: 28650b5a-ed6f-199c-e063-6394a90a9dac
Version: 3
Effective date: 2024-12-03
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:35:58

Harmonized routes table
Harmonized routes
CUTANEOUS

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Bite and Itch	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Weeks & Leo Co., Inc.	openfda.manufacturer_name
ndc	package	11383-192-01	openfda.package_ndc
ndc	package	11383-192-04	openfda.package_ndc
ndc	product	11383-192	openfda.product_ndc
ndc11	package	11383019204	derived:openfda.package_ndc
ndc11	package	11383019201	derived:openfda.package_ndc
rxcui		1292321	openfda.rxcui
spl id		28650b5a-ed6f-199c-e063-6394a90a9dac	id
spl set id		0a4d471b-c3f3-0a6a-e063-6394a90ad57b	set_id
unii		88AYB867L5	openfda.unii
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 For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if condition gets worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on large areas of the body with any other product containing diphynhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if conditions get worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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