Home NDC 51660-066-30 Cetirizine Hydrochloride
Product NDC 51660-066
Requested package NDC 51660-066-30
11-digit product format 516600066
Labeler code 51660
Product ID 51660-066_53580728-757e-08a5-e063-6394a90acb2e
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler OHM LABORATORIES INC.
Application ANDA090142
Marketing category ANDA
Marketing start 2022-07-21
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 2027-12-31
Current FDA listing Yes 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 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2011-08-30
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 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 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
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 1014674 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 51660-066-30 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET, CHEWABLE 30 1 51660-066-30 Cetirizine Hydrochloride 1 in 1 CARTON TABLET, CHEWABLE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51660-066 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [OHM LABORATORIES INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220731_97802669-b4bd-4807-b3c1-6c6f5a2b0c67.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51660-066-30 51660006630 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2022-07-21 0000-00-00 No No Current