Home NDC 49035-312 Equate Allergy Relief
Product NDC 49035-312
11-digit product format 490350312
Labeler code 49035
Product ID 49035-312_a0391ab1-e9cf-47cb-982d-992bd6a7ddf8
Type HUMAN OTC DRUG
Nonproprietary name cetirizine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wal-Mart Stores, Inc.
Application ANDA077318
Marketing category ANDA
Marketing start 2013-07-25
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2013-07-25 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2013-07-25
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 3 · 86 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 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077318-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2013-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077318-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2013-07-25 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cetirizine hydrochloride ACTIVE INGREDIENT 64O047KTOA EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 cetirizine ACTIVE MOIETY YO7261ME24 EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 hydroxypropyl cellulose, low substituted INACTIVE INGREDIENT 2165RE0K14 EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 hypromellose 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-312 EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC.] 2 Legacy NDC 20151204_d641a0ac-9d74-440a-94fd-699ab0fe513d.zip