Home NDC 58602-444 Cetirizine Hydrochloride (Allergy)
Product NDC 58602-444
11-digit product format 586020444
Labeler code 58602
Product ID 58602-444_09cf1596-6539-44ff-9f90-a0fb1f218b4e
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurohealth LLC
Application ANDA090760
Marketing category ANDA
Marketing start 2015-08-05
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 58602-444 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 58602-444 58602-444-48 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 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…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…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014676 Internal RxNorm lookup 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 58602-444-09 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 11 58602-444-09 Cetirizine Hydrochloride (Allergy) 30 in 1 BOTTLE TABLET 30 11 58602-444-17 Cetirizine Hydrochloride (Allergy) 45 in 1 BOTTLE TABLET 45 11 58602-444-17 Cetirizine Hydrochloride (Allergy) 1 in 1 CARTON TABLET 1 11 58602-444-21 Cetirizine Hydrochloride (Allergy) 10 in 1 CARTON TABLET 10 11 58602-444-21 Cetirizine Hydrochloride (Allergy) 10 in 1 BLISTER PACK TABLET 10 11 58602-444-41 Cetirizine Hydrochloride (Allergy) 1000 in 1 BOTTLE TABLET 1000 11 58602-444-47 Cetirizine Hydrochloride (Allergy) 75 in 1 PACKAGE, COMBINATION TABLET 75 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-444 CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC] 11 Current NDC, Legacy NDC, 8 package rows 20240915_3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25.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 Marketing end Sample Exclude flag Status 58602-444-09 58602044409 1 BOTTLE in 1 CARTON (58602-444-09) / 30 TABLET in 1 BOTTLE 1 bottle 2015-08-05 0000-00-00 No No Current 58602-444-17 58602044417 1 BOTTLE in 1 CARTON (58602-444-17) / 45 TABLET in 1 BOTTLE 1 bottle 2015-08-05 0000-00-00 No No Current 58602-444-21 58602044421 10 BLISTER PACK in 1 CARTON (58602-444-21) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2015-08-05 0000-00-00 No No Current 58602-444-41 58602044441 1000 TABLET in 1 BOTTLE (58602-444-41) 1000 tablet 2015-08-05 0000-00-00 No No Current 58602-444-47 58602044447 75 TABLET in 1 PACKAGE, COMBINATION (58602-444-47) 75 tablet 2015-08-05 0000-00-00 No No Current