ZYRTEC

Primary DI
00300450141026
Brand
ZYRTEC
Company
Kenvue Brands LLC
Model
00300450141026
Device description
ZYRTEC Allergen Shield Spray 100 count
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUPCREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUPCream, Nasal, Topical, Mechanical Allergen Particle BarrierGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132520000NASAL EASE ALLERGY BLOCKERHi-Tech Pharmacal, Inc.2013-12-31NUP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300450141026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300450141026003004501410263004501410260300450141026

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/periocular allergen barrier agentA material intended to be applied to the nostrils and/or skin around the nostrils and/or eyes to create a barrier and protect the nasal passages and/or eyes from exposure to allergens (e.g., pollen, dust, pet allergens). It is composed of one or a combination of compounds (e.g., wax, herbal extracts, essential oils) and may be available in various forms (e.g., ointment, resin, gel-forming powder) for use by a layperson in the home or similar environment. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep the bottle and especially nozzle dry at all times. Do not rinse the bottle with water or any other liquid. Store at room temperature, away from moisture. Once opened, use within 3 months.

Contacts#

Phone, Email table
PhoneEmail
+1(800)343-7805xx@xx.com

Regulatory Flags#

DUNS number
118772437
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300450141019ZYRTEC003004501410192026-05-29
00312547202282Listerine003125472022822025-01-01
00312547202299Listerine003125472022992025-01-01
00312547235952Listerine003125472359522017-12-10
00312547235976Listerine003125472359762017-12-10
00381372020453Johnson & Johnson First Aid003813720204532022-01-31
00381372020118Johnson & Johnson First Aid003813720201182021-08-16
00381372020682Johnson & Johnson Red Cross003813720206822021-07-30
00381371192533BAND-AID Brand Adhesive Bandages003813711925332021-02-01
00381371194827Johnson & Johnson First Aid003813711948272020-04-06
00070501101247Neutrogena000705011012472016-09-30
00070501101261Neutrogena000705011012612016-09-30
00070501101315Neutrogena000705011013152017-07-08
00070501260364Neutrogena000705012603642017-08-11
00070501260395Neutrogena000705012603952017-08-11
00070501302743Neutrogena000705013027432017-08-11
00074300012537Visine000743000125372016-09-05
00312547235969Listerine003125472359692017-12-10
00381370055679BAND-AID Brand Adhesive Bandages003813700556792018-09-12
00381370055709BAND-AID Brand Adhesive Bandages003813700557092018-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00300450141019ZYRTECKenvue Brands LLCNUP2026-05-29
00368093000001AllerBlock-AdultWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
00368093000025Allerblock- TravelWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
10368093000008AllerBlock-AdultWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
10368093000022Allerblock- TravelWISCONSIN PHARMACAL COMPANY, LLCNUP2020-09-01
00370914030012Alzair HUDSON SCIENTIFIC, LLCNUP2017-09-19