Home NDC 50090-4173-0 cetirizine hydrochloride
Product NDC 50090-4173
Requested package NDC 50090-4173-0
11-digit product format 500904173
Labeler code 50090
Product ID 50090-4173_47910875-0f88-46f7-a5c8-7ef532e211e9
Type HUMAN OTC DRUG
Nonproprietary name cetirizine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090254
Marketing category ANDA
Marketing start 2008-04-15
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-04-09 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-04-09
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 3 · 82 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 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090254-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090254-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-09 782e0a99824c…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4173-0 cetirizine hydrochloride 1 in 1 CARTON SOLUTION 1 1 50090-4173-0 cetirizine hydrochloride 118 mL in 1 BOTTLE SOLUTION 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4173 CETIRIZINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 2 package rows 20190326_2b348ce4-7c6e-488f-a781-17b26a170762.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 1 · 2 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 50090-4173-0 50090417300 1 BOTTLE in 1 CARTON (50090-4173-0) > 118 mL in 1 BOTTLE 1 bottle 2019-03-07 0000-00-00 No No Current