Home NDC 72288-691-09 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF
Product NDC 72288-691
Requested package NDC 72288-691-09
11-digit product format 722880691
Labeler code 72288
Product ID 72288-691_ea26086f-6878-4d85-94a0-ca08caef7f4e
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Amazon.com Services LLC
Application ANDA090760
Marketing category ANDA
Marketing start 2024-05-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-08-05 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-08-05 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-08-05 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-08-05
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 · 180 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 2026-11-14 07:37:17 2026-10 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AMAZON BASIC CARE ALL DAY ALLERGY RELIEF
Listing expiration 2027-12-31 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 72288-691-09 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72288-691-09 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 30 in 1 BOTTLE TABLET 30 2 72288-691-19 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72288-691-19 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 90 in 1 BOTTLE TABLET 90 2 72288-691-38 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 300 in 1 BOTTLE TABLET 300 2 72288-691-38 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72288-691-39 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72288-691-39 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF 365 in 1 BOTTLE TABLET 365 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72288-691 AMAZON BASIC CARE ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [AMAZON.COM SERVICES LLC] 2 Current NDC, 8 package rows 20240515_113e66f1-b922-8533-e063-6294a90ab30e.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 · 15 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72288-691-09 72288069109 1 BOTTLE in 1 CARTON (72288-691-09) / 30 TABLET in 1 BOTTLE 1 bottle 2024-05-15 No No Current