Orajel Complete Protection

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: Orajel Complete Protection
Generic name: SODIUM FLUORIDE
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: daebd16f-d278-446d-8b7a-33add5a74fdd
SPL ID: 1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Version: 3
Effective date: 2023-12-19
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:40:55

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Orajel Complete Protection	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-677-12	openfda.package_ndc
ndc	package	10237-677-43	openfda.package_ndc
ndc	product	10237-677	openfda.product_ndc
ndc11	package	10237067712	derived:openfda.package_ndc
ndc11	package	10237067743	derived:openfda.package_ndc
spl id		1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd	id
spl set id		daebd16f-d278-446d-8b7a-33add5a74fdd	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

Warnings Do not use if irritation occurs and persists. When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. 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. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally 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.