Home NDC 80136-856 Cetirizine HCl
Product NDC 80136-856
11-digit product format 801360856
Labeler code 80136
Product ID 80136-856_0647ef67-e7f9-a73e-e063-6294a90abe76
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form CAPSULE
Route ORAL
Labeler Northeast Pharma
Application NDA022429
Marketing category NDA
Marketing start 2023-09-26
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 2027-12-31
Current FDA listing Yes 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 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE / ORAL RLD 2009-07-23 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL RLD, RS 2009-07-23 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE / ORAL RLD 2009-07-23 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL RLD, RS 2009-07-23
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 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG CAPSULE / ORAL RLD 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG CAPSULE / ORAL RLD, RS 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG CAPSULE / ORAL RLD 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL RLD, RS 2009-07-23 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 HCl
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 1014675 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 80136-856-23 Cetirizine HCl 25 in 1 BOTTLE, PLASTIC CAPSULE 25 1 80136-856-23 Cetirizine HCl 1 in 1 CARTON CAPSULE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80136-856 CETIRIZINE HCL CAPSULE [NORTHEAST PHARMA] 1 Current NDC, 2 package rows 20230928_0647ef4c-8912-9f44-e063-6294a90ae3a6.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80136-856-23 80136085623 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC 2023-09-26 No No Current