ZYRTEC-D

Manufacturer: Kenvue Brands LLC
Effective date: 2026-04-06
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:53:44

Label at a glance#

ProductZYRTEC-D

Active ingredientCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage and administration

do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if blister unit is torn or broken

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active ingredients (in each extended release tablet)*	*Purpose*
Cetirizine HCl 5 mg	Antihistamine
Pseudoephedrine HCl 120 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

do not use more than directed
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)
do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-719-24

ZYRTEC-D ^®

Cetirizine HCl5 mg/antihistamine
Pseudoephedrine HCl 120 mg/ nasal decongestant
Extended Release Tablets

Indoor &

Outdoor

Allergies

ALLERGY

+ SINUS

NASAL CONGESTION

+ SINUS PRESSURE

12
Hour

relief of

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Actual Size

24
EXTENDED

RELEASE

TABLETS

Zyrtec-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014571	cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	6
1014583	ZyrTEC-D Allergy & Congestion 5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	6
1014583	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Zyrtec-D]	SBD	6
1014571	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	6
1014571	cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	6
1014583	Zyrtec-D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral Tablet	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0300450204240	GTIN-13: 0300450204240 EAN-13: 0300450204240 GTIN-12: 300450204240 UPC-A: 300450204240 GTIN storage (14 digits): 00300450204240	Zyrtec-1.jpg
Data code	Code 128	30061092		Zyrtec-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-719-12	ZYRTEC-D	2 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	2	6
50580-719-12	ZYRTEC-D	6 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	6	6
50580-719-24	ZYRTEC-D	4 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	4	6
50580-719-24	ZYRTEC-D	6 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	6	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-719-12	EA - Each	50580-719	46184429-04f2-40ca-a85f-3ae4eb72c2aa	1	2023-06-06
50580-719-24	EA - Each	50580-719	a371d5a4-5df3-481a-8f99-4496068de2fb	1	2023-04-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

ZYRTEC-D
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-719	50580-719-12, 50580-719-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021150-002	ZYRTEC-D 12 HOUR	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2007-11-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021150-002	ZYRTEC-D 12 HOUR	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2007-11-09	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021150-002	7014867	2022-06-10		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021150-002	7226614	2022-06-10	U-295		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021150-002	7014867	2022-06-10		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021150-002	7226614	2022-06-10	U-295		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021150-002	7014867	2022-06-10		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021150-002	7226614	2022-06-10	U-295		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021150-002	6469009	2019-07-13	U-295	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021150-002	7014867	2022-06-10		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021150-002	7226614	2022-06-10	U-295		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021150-002	7014867	2022-06-10		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021150-002	7226614	2022-06-10	U-295		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021150-002	7014867	2022-06-10		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021150-002	7226614	2022-06-10	U-295		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021150-002	7014867	2022-06-10		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021150-002	7226614	2022-06-10	U-295		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021150-002	7014867	2022-06-10		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021150-002	7226614	2022-06-10	U-295		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021150-002	7014867	2022-06-10		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021150-002	7226614	2022-06-10	U-295		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021150-002	7014867	2022-06-10		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021150-002	7226614	2022-06-10	U-295		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021150-002	6469009	2019-07-13	U-295	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021150-002	7014867	2022-06-10		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021150-002	7226614	2022-06-10	U-295		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021150-002	6469009	2019-07-13	U-295	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021150-002	7014867	2022-06-10		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021150-002	7226614	2022-06-10	U-295		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021150-002	6469009	2019-07-13	U-295	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021150-002	7014867	2022-06-10		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021150-002	7226614	2022-06-10	U-295		`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021150-002	7014867	2022-06-10		Drug product	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021150-002	7226614	2022-06-10	U-295		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021150-002	7014867	2022-06-10		Drug product	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021150-002	7226614	2022-06-10	U-295		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021150-002	7014867	2022-06-10		Drug product	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021150-002	7226614	2022-06-10	U-295		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021150-002	7014867	2022-06-10		Drug product	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021150-002	7226614	2022-06-10	U-295		`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021150-002	7014867	2022-06-10		Drug product	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021150-002	7226614	2022-06-10	U-295		`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYRTEC-D	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	f1ecf9ba-1c03-7fb7-e053-2a95a90a875a	2026-04-06	Warnings	Exact identifier ndc (package): 50580-719-12 ndc (package): 50580-719-24 ndc (product): 50580-719 ndc11 (package): 50580071912 ndc11 (package): 50580071924 spl id: 4ec5aa70-7743-2cf9-e063-6394a90a06dd spl set id: f1ecf9ba-1c03-7fb7-e053-2a95a90a875a

Reported adverse events (FAERS/openFDA)#

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