Home NDC 67414-013 Zyrtec Allergy Cetirizine HCl
Product NDC 67414-013
11-digit product format 674140013
Labeler code 67414
Product ID 67414-013_59cef44f-7fdf-736c-e063-6294a90ae4b6
Type HUMAN OTC DRUG
Nonproprietary name CETIRIZINE HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Jones Healthcare Group - Packaging Services, Inc
Application ANDA213105
Marketing category ANDA
Marketing start 2026-06-30
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL 2020-09-21
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.
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 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a50c72e98297…
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 Zyrtec Allergy 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014675 Internal RxNorm lookup 1020023 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 18 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy Relief CETIRIZINE HCL CVS PHARMACY, INC fb850a4c-7ac1-4993-b6ea-5c8d42e17703 2026-08-26 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Zyrtec Allergy Cetirizine HCl CETIRIZINE HYDROCHLORIDE Jones Healthcare Group - Packaging Services, Inc 59cf7672-fdde-ddbd-e063-6394a90a223b 2026-08-24 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Zyrtec Allergy Cetirizine HCl CETIRIZINE HYDROCHLORIDE Jones Healthcare Group - Packaging Services, Inc 59cef432-41ac-768c-e063-6294a90a38fa 2026-08-19 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 67414-013 Allergy Relief CETIRIZINE HCL WALMART INC. (see also Equate) 967be504-85b1-4e9b-9b08-2b27a43fa0aa 2026-06-18 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Allergy Relief CETIRIZINE HCL CVS PHARMACY, INC a57a0dbe-0926-4b25-a5d7-b8d499d67158 2026-05-18 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 All Day Allergy CETIRIZINE HCL WALMART INC. (see also Equate) c8016d34-aa72-4857-b5ed-5476948b386a 2026-02-20 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Allergy Relief CETIRIZINE HCL Safeway, Inc. 1fbb274c-cacc-4ba9-be97-33d83e2773db 2025-12-16 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ZYRTEC Allergy CETIRIZINE HYDROCHLORIDE Kenvue Brands LLC 0face45c-af24-3559-e063-6294a90abde5 2025-10-21 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 All Day Allergy Relief CETIRIZINE HCL P & L Development, LLC 7dabf6bd-8a96-4e7f-bc19-5a47cec36419 2025-05-16 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 basic care all day allergy CETIRIZINE HYDROCHLORIDE Amazon.com Services LLC e71e259a-494e-4a9a-b0e4-25bd25dd0e07 2025-04-06 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Allergy Relief CETIRIZINE HCL H E B 4bbf0be5-7bcc-46c6-a443-7b37d4679c6f 2024-05-10 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 topcare all day allergy CETIRIZINE HYDROCHLORIDE Topco Associates LLC 10c512a1-bb96-4d2a-9e41-a422efb57e28 2023-02-09 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Allergy Relief CETIRIZINE HCL CVS PHARMACY, INC ed8951a1-bd7e-439d-a427-685d56a9c9ad 2022-11-07 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 careone allergy relief CETIRIZINE HYDROCHLORIDE Retail Business Services, LLC 6d94d302-b79a-4143-bb3c-c74da2a6a72e 2022-10-20 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Allergy Relief CETIRIZINE HCL Care One (Retail Business Services, LLC.) 04a6087e-d854-4e70-9d89-3971890a44a3 2022-10-20 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 Good Sense All Day Allergy CETIRIZINE HYDROCHLORIDE L. Perrigo Company 5b1203c7-9678-4cee-9d7b-6510da295561 2022-09-08 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 dg health all day allergy CETIRIZINE HYDROCHLORIDE Dolgencorp Inc 6baa66e7-93df-43d9-a301-5d9c14274c99 2022-04-01 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105 allergy relief CETIRIZINE HYDROCHLORIDE Publix Super Markets Inc 268170c9-b6a7-4851-b7d3-33dd1d733e39 2022-03-07 Warnings Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67414-013-01 67414001301 1 BOTTLE in 1 CARTON (67414-013-01) / 12 CAPSULE in 1 BOTTLE 1 bottle 2026-06-30 No No Current 67414-013-02 67414001302 1 BOTTLE in 1 CARTON (67414-013-02) / 25 CAPSULE in 1 BOTTLE 1 bottle 2026-06-30 No No Current 67414-013-03 67414001303 1 BOTTLE in 1 CARTON (67414-013-03) / 40 CAPSULE in 1 BOTTLE 1 bottle 2026-06-30 No No Current