Home NDC 46994-658 Allergy Relief
Product NDC 46994-658
11-digit product format 469940658
Labeler code 46994
Product ID 46994-658_ee27dfb4-1eee-eb54-e053-2995a90ab1de
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SAVE-A-LOT FOOD STORES, LTD.
Application ANDA077829
Marketing category ANDA
Marketing start 2020-03-13
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 46994-658-14 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 46994-658-14 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 46994-658-14 bd6a592717d7…303034d00443…
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 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL RS 2009-08-26 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-08-26
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 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 5bbf6a4d5a75…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46994-658-14 Allergy Relief 1 in 1 CARTON TABLET, FILM COATED 1 5 46994-658-14 Allergy Relief 14 in 1 BOTTLE TABLET, FILM COATED 14 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46994-658 ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] 5 Legacy NDC, 2 package rows 20241222_b25a758f-8fde-4c75-a861-1e4e366e4838.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 2 · 26 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 46994-658-14 46994065814 1 BOTTLE in 1 CARTON (46994-658-14) > 14 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-03-13 0000-00-00 No No Current