Home NDC 0363-4101 allergy relief
Product NDC 0363-4101
11-digit product format 003634101
Labeler code 0363
Product ID 0363-4101_28f9d48e-60ee-4d58-af55-0b6206044e31
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application ANDA078336
Marketing category ANDA
Marketing start 2021-10-21
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27
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 · 164 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 2026-02-19 14:30 UTC 2026-02 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base allergy relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64O047KTOA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014678 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-4101-13 allergy relief 5 in 1 CARTON TABLET, FILM COATED 5 6 0363-4101-13 allergy relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 0363-4101-39 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-39 allergy relief 30 in 1 BOTTLE TABLET, FILM COATED 30 6 0363-4101-47 allergy relief 150 in 1 BOTTLE TABLET, FILM COATED 150 6 0363-4101-47 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-58 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-58 allergy relief 40 in 1 BOTTLE TABLET, FILM COATED 40 6 0363-4101-66 allergy relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 0363-4101-66 allergy relief 14 in 1 CARTON TABLET, FILM COATED 14 6 0363-4101-72 allergy relief 60 in 1 BOTTLE TABLET, FILM COATED 60 6 0363-4101-72 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-75 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-75 allergy relief 90 in 1 BOTTLE TABLET, FILM COATED 90 6 0363-4101-88 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-88 allergy relief 365 in 1 BOTTLE TABLET, FILM COATED 365 6 0363-4101-95 allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 6 0363-4101-95 allergy relief 45 in 1 BOTTLE TABLET, FILM COATED 45 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-4101 ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY] 5 Current NDC, Legacy NDC, 18 package rows 20241215_678dcc09-55da-4d9d-a39a-c450c61c387b.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 3 · 44 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-4101-13 00363410113 5 BLISTER PACK in 1 CARTON (0363-4101-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2022-03-30 0000-00-00 No No Current 0363-4101-39 00363410139 1 BOTTLE in 1 CARTON (0363-4101-39) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-12-06 0000-00-00 No No Current 0363-4101-47 00363410147 1 BOTTLE in 1 CARTON (0363-4101-47) / 150 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-05-02 No No Current 0363-4101-58 00363410158 1 BOTTLE in 1 CARTON (0363-4101-58) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-12-13 No No Current 0363-4101-66 00363410166 1 in 1 BLISTER PACK Historical 0363-4101-72 00363410172 1 BOTTLE in 1 CARTON (0363-4101-72) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-06-17 No No Current 0363-4101-75 00363410175 1 BOTTLE in 1 CARTON (0363-4101-75) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-10-21 0000-00-00 No No Current 0363-4101-88 00363410188 1 BOTTLE in 1 CARTON (0363-4101-88) / 365 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-03-08 0000-00-00 No No Current 0363-4101-95 00363410195 1 BOTTLE in 1 CARTON (0363-4101-95) / 45 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-03-25 No No Current