H-E-B

Product NDC
37808-208
11-digit product format
378080208
Labeler code
37808
Product ID
37808-208_cfe60090-ff71-40dc-9eca-2a2a8e7865ae
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA090182
Marketing category
ANDA
Marketing start
2008-04-22
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37808-208IInactivated by FDA2026-08-03
excluded packagepackage37808-20837808-208-88IInactivated by FDA2026-08-03

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-208-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-208-88f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-208-882ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-208-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-208-88cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-208-88cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-208-88302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-208-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-208-880efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-208-88ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-208-88367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-208-88557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37808-208-888af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37808-208-88834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37808-208-881332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37808-208-88fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37808-208-8886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37808-208-88bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37808-208-888dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37808-208-88e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage37808-208-889bebd1f3094a…5416666fcb17…

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
A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22
A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22

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 · 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 UTC2026-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-208-882020-01-31C16284748780-19d75b9d0-3bd7-f424-e053-dadaa90a57ceH-E-B ® Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-208-88H-E-B Allergy Relief120 mL in 1 BOTTLESOLUTION1201
37808-208-88H-E-B Allergy Relief1 in 1 CARTONSOLUTION11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-208H-E-B ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]1Legacy NDC, 2 package rows20121212_a33061ab-622d-46ea-81d2-6148e1684e8e.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb73950f4-af6f-4dc7-bce2-9ec43c45eee52026-06-12WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.30cbaa91-2216-efd2-e063-6294a90aaaed2026-06-07WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
HEB Allergy ReliefCETIRIZINE HYDROCHLORIDEH E B9abdae64-4c3d-47f3-8224-fc81f7bfe5572026-05-31WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEVERITYRX, LLC42a1168e-e2cd-a1e5-e063-6294a90ab3b62025-11-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
childrens allergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Incae216d0b-8ccc-4cc4-82f4-4d0f3a2568222025-07-15WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Premier Value Childrens CetirizineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLCa4931f0b-86f2-42c5-b2df-b359bb46f44a2025-07-11WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC601c2846-30e7-40f1-96b4-64fbed719c0b2025-07-10WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.54d72d7a-1f5b-4b36-bf76-ab7aef6243ab2025-07-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
SIMPLY RIGHT childrens cetirizineCETIRIZINE HYDROCHLORIDESam's West Inc48b47541-cf0c-48a7-9a65-2158fd1284f12024-06-24WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC (Premier Value)b47b0c8b-59d5-4e17-95be-a992c6861ee72019-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa33061ab-622d-46ea-81d2-6148e1684e8e1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa33061ab-622d-46ea-81d2-6148e1684e8e1
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa33061ab-622d-46ea-81d2-6148e1684e8e1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa33061ab-622d-46ea-81d2-6148e1684e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
37808-208-8837808020888120 mL in 1 BOTTLE120 mlHistorical