Intensive Enamel Repair Whitening TP

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: Intensive Enamel Repair Whitening TP
Generic name: INTENSIVE ENAMEL REPAIR WHITENING TP
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3012a8da-7595-2f7c-e063-6294a90ae120
SPL ID: 400555cb-e40f-5d08-e063-6394a90a160a
Version: 4
Effective date: 2025-09-30
Source export date: 2026-10-27
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/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:07:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Intensive Enamel Repair Whitening TP	openfda.brand_name
generic name		INTENSIVE ENAMEL REPAIR WHITENING TP	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-362-00	openfda.package_ndc
ndc	package	36800-362-10	openfda.package_ndc
ndc	product	36800-362	openfda.product_ndc
ndc11	package	36800036200	derived:openfda.package_ndc
ndc11	package	36800036210	derived:openfda.package_ndc
rxcui		1086243	openfda.rxcui
spl id		400555cb-e40f-5d08-e063-6394a90a160a	id
spl set id		3012a8da-7595-2f7c-e063-6294a90ae120	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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

When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children . If more than used for brushing is acidentally 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.