FDA.reportPublic FDA data

NDC 51672-4070-08 - Cetirizine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-4070
Requested NDC
51672-4070-08
Package NDCs from labels
51672-4070-8, 51672-4070-08
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL)Preferred Pharmaceuticals Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL
Cetirizine Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL)Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2025-08-01HUMAN PRESCRIPTION DRUG LABEL
Cetirizine Hydrochloride - Proficient Rx LPProficient Rx LP2024-07-01HUMAN PRESCRIPTION DRUG LABEL
Cetirizine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2024-03-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4070-8Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION12014
51672-4070-8Cetirizine Hydrochloride1 in 1 CARTONSOLUTION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4070CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]12Current NDC, Legacy NDC, 2 package rows20250116_6d81446e-f713-4ca4-af38-3d31cf618873.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4070-8ML - Milliliter51672-4070c31539f4-c130-4a4e-bf9d-dcb5df28f8de12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sucroseINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2

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 9 of 54 · 1,072 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Sodium AcetateSODIUM ACETATEHospira, Inc.ce9a7469-c4ba-4f60-8f7a-47ef0974316e2026-03-26Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Sodium AcetateSODIUM ACETATEHospira, Inc.c91ede49-c7cc-47b7-0f93-e6841dd5916a2026-03-26Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Sodium AcetateSODIUM ACETATEHospira, Inc.abc41ed1-9512-4bea-9295-1a9ca134b6c22026-03-26Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Sodium AcetateSODIUM ACETATEHospira, Inc.c3be2468-45e8-4ecc-a30b-e966743a563f2026-03-26Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
childrens cetirizine hydrochlorideCETIRIZINE HCLPreferred Pharmaceuticals Inc.9e168299-5ba1-451a-8c85-3fbe34c36cb02026-03-25WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e874264a-becc-45d0-b934-779eab5f50852026-03-25Adverse reactionsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSPreferred Pharmaceuticals Inc.14a885e5-5e75-4a18-b5bc-6aaa748712db2026-03-25WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.73122009-531b-4929-bf57-494a6fc65b732026-03-25WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7e94be37-0971-44b3-9857-f56330d810b62026-03-25Adverse reactionsExact identifier
application number: ANDA076601
ndc (package): 68788-8282-1
ndc (product): 68788-8282
rxcui: 1014673
spl id: f7c9f293-13da-4906-9a17-f8f18b6ba807
spl set id: 7e94be37-0971-44b3-9857-f56330d810b6
unii: 64O047KTOA
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBryant Ranch Prepack9c11dd22-cb17-4179-8c54-1d515bf662d22026-03-20WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a7da81e1-8865-45c9-83c7-32fb8032ca2e2026-03-19WarningsExact identifier
unii: 64O047KTOA
CetirizineCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack7e158fd6-268d-4ffc-a410-d054090d54c52026-03-19WarningsExact identifier
unii: 64O047KTOA
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Indoor and Outdoor Allergy ReliefCETIRIZINE HCLFamora Inc.2a94d25c-aacf-4f5c-b406-815f0e1d06112026-03-18WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.