Home NDC 69842-237-91 Cetirizine Hydrochloride (Allergy)
Product NDC 69842-237
Requested package NDC 69842-237-91
11-digit product format 698420237
Labeler code 69842
Product ID 69842-237_621f3d87-d69e-41e6-8ece-22099cb87c01
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler CVS Pharmacy, Inc.
Application ANDA090760
Marketing category ANDA
Marketing start 2019-07-26
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 · 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 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 · 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 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…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2015-08-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET / ORAL 2015-08-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2015-08-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET / ORAL 2015-08-05 5bbf6a4d5a75…
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 Cetirizine Hydrochloride (Allergy)
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 69842-237-01 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-01 Cetirizine Hydrochloride (Allergy) 14 in 1 BLISTER PACK TABLET 14 7 69842-237-09 Cetirizine Hydrochloride (Allergy) 30 in 1 BOTTLE TABLET 30 7 69842-237-09 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-17 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-17 Cetirizine Hydrochloride (Allergy) 45 in 1 BOTTLE TABLET 45 7 69842-237-19 Cetirizine Hydrochloride (Allergy) 90 in 1 BOTTLE TABLET 90 7 69842-237-19 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-23 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-23 Cetirizine Hydrochloride (Allergy) 120 in 1 BOTTLE TABLET 120 7 69842-237-39 Cetirizine Hydrochloride (Allergy) 365 in 1 BOTTLE TABLET 365 7 69842-237-45 Cetirizine Hydrochloride (Allergy) 2 in 1 CARTON TABLET 2 7 69842-237-45 Cetirizine Hydrochloride (Allergy) 120 in 1 BOTTLE TABLET 120 7 69842-237-54 Cetirizine Hydrochloride (Allergy) 70 in 1 BOTTLE TABLET 70 7 69842-237-54 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-57 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-57 Cetirizine Hydrochloride (Allergy) 5 in 1 BLISTER PACK TABLET 5 7 69842-237-60 Cetirizine Hydrochloride (Allergy) 5 in 1 BLISTER PACK TABLET 5 7 69842-237-60 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-91 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 7 69842-237-91 Cetirizine Hydrochloride (Allergy) 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-237 CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [CVS PHARMACY, INC.] 7 Current NDC, Legacy NDC, 21 package rows 20240331_e340cd4b-5413-42c6-a956-eb15c3807aeb.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 · 18 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 69842-237-91 69842023791 1 BOTTLE in 1 CARTON (69842-237-91) > 30 TABLET in 1 BOTTLE 1 bottle 2019-07-26 0000-00-00 No No Current