Home NDC 50580-779-65 ZYRTEC
Product NDC 50580-779
Requested package NDC 50580-779-65
11-digit product format 505800779
Labeler code 50580
Product ID 50580-779_cea20e63-c9ab-38c7-e053-2995a90adebe
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application NDA022429
Marketing category NDA
Marketing start 2010-02-08
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50580-779 50580-779-65 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE / ORAL RLD 2009-07-23 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL RLD, RS 2009-07-23 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE / ORAL RLD 2009-07-23 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL RLD, RS 2009-07-23
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 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cetirizine Hydrochloride ACTIVE INGREDIENT 64O047KTOA ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 Cetirizine ACTIVE MOIETY YO7261ME24 ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 gelatin INACTIVE INGREDIENT 2G86QN327L ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 glycerin INACTIVE INGREDIENT PDC6A3C0OX ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 mannitol INACTIVE INGREDIENT 3OWL53L36A ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 sorbitan INACTIVE INGREDIENT 6O92ICV9RU ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 sorbitol INACTIVE INGREDIENT 506T60A25R ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4 water INACTIVE INGREDIENT 059QF0KO0R ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-779 ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC] 13 Legacy NDC 20241109_605adf29-734f-451a-8ff3-74be7b5814a6.zip
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 2 · 23 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-779-65 50580077965 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-779-65) 2010-02-08 0000-00-00 No No Current