Home NDC 68196-102-01 SIMPLY RIGHT
Product NDC 68196-102
Requested package NDC 68196-102-01
11-digit product format 681960102
Labeler code 68196
Product ID 68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Sam's West Inc
Application ANDA090182
Marketing category ANDA
Marketing start 2011-09-08
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-04-22 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2008-04-22
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 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2008-04-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2008-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090182-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2008-04-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090182-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2008-04-22 74a2ff9319b5…
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 SIMPLY RIGHT
Brand name suffix childrens cetirizine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 mg/5mL
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 1014673 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 68196-102-01 SIMPLY RIGHTchildrens cetirizine 2 in 1 CARTON SOLUTION 2 5 68196-102-01 SIMPLY RIGHTchildrens cetirizine 240 mL in 1 BOTTLE SOLUTION 240 5 68196-102-02 SIMPLY RIGHTchildrens cetirizine 120 mL in 1 BOTTLE SOLUTION 120 5 68196-102-02 SIMPLY RIGHTchildrens cetirizine 2 in 1 CARTON SOLUTION 2 5 68196-102-07 SIMPLY RIGHTchildrens cetirizine 240 mL in 1 BOTTLE SOLUTION 240 5 68196-102-07 SIMPLY RIGHTchildrens cetirizine 2 in 1 CARTON SOLUTION 2 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-102 SIMPLY RIGHT CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [SAM'S WEST INC] 5 Current NDC, Legacy NDC, 6 package rows 20240625_48b47541-cf0c-48a7-9a65-2158fd1284f1.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 · 12 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 68196-102-01 68196010201 2 BOTTLE in 1 CARTON (68196-102-01) > 240 mL in 1 BOTTLE 2 bottle 2011-09-08 0000-00-00 No No Current