Therabreath Rinse

FDA UDI

Class U (US FDA UDI)

by Church & Dwight Co., Inc.

Identity

Trade Name: THERABREATH RINSE FDA UDI
Generic Name: Artificial saliva FDA UDI
Device Name: Dry Mouth Rinse FDA UDI
Model / Reference: 00697029507032 FDA UDI
Description: Dry Mouth Rinse FDA UDI

Identifiers

Primary DI / UDI-DI: 00697029507032 FDA UDI
510(k) Number: K171542 FDA UDI
FDA Product Code: LFD FDA UDI
GMDN Term: Artificial saliva FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Artificial saliva

Therabreath Rinse by Church & Dwight Co., Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Artificial saliva.

Biotene — Haleon US Holdings LLC · U
Biotene — Haleon US Holdings LLC · U
Moisyn Dry Mouth Oral Mist — Synedgen, Inc. · U
Salivea — Laclede, Inc. · U
SalivaMAX — FORWARD SCIENCE TECHNOLOGIES LLC · U
Biotene Oral Rinse Dry Mouth — Haleon US Holdings LLC · U
Periovance Dry Mouth Gel — ORABIO, INC. · U
Biotene — Haleon US Holdings LLC · U

Cleared under the same submission

K171542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Church & Dwight Co., Inc.

Sources (1)

FDA UDI 640133db-de6a-43e4-992a-6e0022461e43 35 fields · synced Jun 9, 2026