PBZ OTC

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: PBZ OTC
Generic name: TRIPELENNAMINE HCL 1%
Manufacturer: Kingsway Pharmaceuticals dba NFI, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 12f72d74-018f-4bc6-acd4-175ca3af4c6d
SPL ID: d144cc3d-1fca-4a3e-932c-7ca07b85068b
Version: 3
Effective date: 2025-08-29
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:06

Harmonized routes table
Harmonized routes
TOPICAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		PBZ OTC	openfda.brand_name
generic name		TRIPELENNAMINE HCL 1%	openfda.generic_name
manufacturer name		Kingsway Pharmaceuticals dba NFI, LLC	openfda.manufacturer_name
ndc	package	69993-151-02	openfda.package_ndc
ndc	package	69993-151-01	openfda.package_ndc
ndc	product	69993-151	openfda.product_ndc
ndc11	package	69993015102	derived:openfda.package_ndc
ndc11	package	69993015101	derived:openfda.package_ndc
rxcui		2711712	openfda.rxcui
spl id		d144cc3d-1fca-4a3e-932c-7ca07b85068b	id
spl set id		12f72d74-018f-4bc6-acd4-175ca3af4c6d	set_id
unii		3C5ORO99TY	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. Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not use if packaging is damaged or opened. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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