Alpha-Pro

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: Alpha-Pro
Generic name: SODIUM FLUORIDE AND HYDROFLUORIC ACID
Manufacturer: Dental Technologies, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: a86ec65f-f6e1-474d-aeff-412a4716a92c
SPL ID: 42c899b3-99ed-0863-e063-6394a90ad112
Version: 3
Effective date: 2025-11-04
Source export date: 2026-11-06
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/3744b3ae389d13e8f30cade845ea29e0fc75bb043dcda980c2025693f0c10522/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:08:14

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Alpha-Pro	openfda.brand_name
generic name		SODIUM FLUORIDE AND HYDROFLUORIC ACID	openfda.generic_name
manufacturer name		Dental Technologies, Inc.	openfda.manufacturer_name
ndc	package	55346-0943-1	openfda.package_ndc
ndc	product	55346-0943	openfda.product_ndc
ndc11	package	55346094301	derived:openfda.package_ndc
rxcui		1297381	openfda.rxcui
spl id		42c899b3-99ed-0863-e063-6394a90ad112	id
spl set id		a86ec65f-f6e1-474d-aeff-412a4716a92c	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RGL5YE86CZ	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

Warning: Keep out of reach of children. Do not swallow. If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Contains FD&C Yellow No.6.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Reported adverse events (FAERS/openFDA)#

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