EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint

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: EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint
Generic name: SODIUM BICARBONATE
Manufacturer: Lotus Brands, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4a95c8c1-db7c-4791-ac58-3eac216a0126
SPL ID: 50ca235d-8d64-436a-bc34-bfca36e7a58e
Version: 4
Effective date: 2024-12-18
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:14

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	openfda.brand_name
generic name		SODIUM BICARBONATE	openfda.generic_name
manufacturer name		Lotus Brands, Inc.	openfda.manufacturer_name
ndc	package	76328-223-01	openfda.package_ndc
ndc	product	76328-223	openfda.product_ndc
ndc11	package	76328022301	derived:openfda.package_ndc
rxcui		1425559	openfda.rxcui
spl id		50ca235d-8d64-436a-bc34-bfca36e7a58e	id
spl set id		4a95c8c1-db7c-4791-ac58-3eac216a0126	set_id
unii		8MDF5V39QO	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 this product as an oral wound cleanser for more than 7 days unless directed by a dentist or doctor Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children If more than used for oral wound cleansing 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.