CVS Dry Mouth Spray

FDA UDI

Class U (US FDA UDI)

by Oralabs, Inc.

Identity

Trade Name: CVS Dry Mouth Spray FDA UDI
Generic Name: Artificial saliva FDA UDI
Device Name: Artificial Saliva - Dry Mouth Spray FDA UDI
Model / Reference: 002 FDA UDI
Description: Artificial Saliva - Dry Mouth Spray FDA UDI

Identifiers

Primary DI / UDI-DI: D132DMS0020 FDA UDI
510(k) Number: K181839 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.5 Fluid Ounce FDA UDI

Category: Artificial saliva

CVS Dry Mouth Spray by Oralabs, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Artificial saliva.

THERABREATH RINSE — Church & Dwight Co., Inc. · U
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
THERABREATH LOZENGE — Church & Dwight Co., Inc. · U

Cleared under the same submission

K181839 also covers:

CVS Dry Mouth Spray — Oralabs, Inc.
Meijer — Oralabs, Inc.

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

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Manufacturer

Manufacturer: Oralabs, Inc.

Sources (1)

FDA UDI 76d0fc66-e71f-44c7-89f3-b1a6665a103c 35 fields · synced May 30, 2026