Home NDC 63868-139-25 All Day Allergy
Product NDC 63868-139
Requested package NDC 63868-139-25
11-digit product format 638680139
Labeler code 63868
Product ID 63868-139_d357d8bf-bd25-49d7-8b06-b20f2738914c
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form CAPSULE
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application NDA022429
Marketing category NDA
Marketing start 2016-04-30
Marketing end 2024-05-31
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 172 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 2026-09-14 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 63868-139-25 63868013925 1 BOTTLE, PLASTIC in 1 PACKAGE (63868-139-25) > 25 CAPSULE in 1 BOTTLE, PLASTIC 2016-04-30 2024-05-31 No No Current