FDA.reportPublic FDA data

childrens allergy relief

Product NDC
37808-671
Requested package NDC
37808-671-26
11-digit product format
378080671
Labeler code
37808
Product ID
37808-671_e5e7b796-c175-4122-9474-238e38990337
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA090254
Marketing category
ANDA
Marketing start
2018-05-18
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-67137808-671-26DDiscontinued by firm2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-09
A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-09

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090254-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A090254-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-09782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-671-26childrens allergy relief1 in 1 CARTONSOLUTION11
37808-671-26childrens allergy relief118 mL in 1 BOTTLESOLUTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-671CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]1Current NDC, Legacy NDC, 2 package rows20180519_e5e7b796-c175-4122-9474-238e38990337.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2025-04-03WarningsExact identifier
application applno (ANDA): 090254
application number: ANDA090254
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdc2cf555d-986c-4e89-ac4f-938e92c418e22025-01-20WarningsExact identifier
application applno (ANDA): 090254
application number: ANDA090254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe5e7b796-c175-4122-9474-238e389903371
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe5e7b796-c175-4122-9474-238e389903371
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe5e7b796-c175-4122-9474-238e389903371
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe5e7b796-c175-4122-9474-238e389903371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-671-26378080671261 BOTTLE in 1 CARTON (37808-671-26) / 118 mL in 1 BOTTLE1 bottle2018-05-180000-00-00NoNoCurrent