Pronamel Repair Whitening

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: Pronamel Repair Whitening
Generic name: FLUORIDE
Manufacturer: Rite Aid
Product type: HUMAN OTC DRUG
SPL set ID: 21645dd5-5cb7-2088-e063-6394a90a61ff
SPL ID: 441ef4c5-4903-159d-e063-6394a90aebd0
Version: 3
Effective date: 2025-11-21
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:36:56

Harmonized routes table
Harmonized routes
DENTAL

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Pronamel Repair Whitening	openfda.brand_name
generic name		FLUORIDE	openfda.generic_name
manufacturer name		Rite Aid	openfda.manufacturer_name
ndc	package	11822-6310-1	openfda.package_ndc
ndc	product	11822-6310	openfda.product_ndc
ndc11	package	11822631001	derived:openfda.package_ndc
rxcui		1086243	openfda.rxcui
spl id		441ef4c5-4903-159d-e063-6394a90aebd0	id
spl set id		21645dd5-5cb7-2088-e063-6394a90a61ff	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 stil persists after 4 weeks of use.

Reported adverse events (FAERS/openFDA)#

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