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 6 of 53 · 1,059 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESavings Distributors LLC5490c38a-91d7-9ee1-e063-6394a90a1ea52026-06-01WarningsExact identifier
unii: 64O047KTOA
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
HEB Allergy ReliefCETIRIZINE HYDROCHLORIDEH E B9abdae64-4c3d-47f3-8224-fc81f7bfe5572026-05-31WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Allergy ReliefCETIRIZINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.ac22558b-5c82-4ab9-95b8-53eedea462822026-05-28WarningsExact identifier
unii: 64O047KTOA
allergy relief-DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporationfdf98201-661c-4b1e-97f6-265807d90f762026-05-27WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCc1ae7bb1-e154-4745-b01e-bc91d50d35c82026-05-25WarningsExact identifier
unii: 64O047KTOA
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefCETIRIZINE HYDROCHLORIDEGrocery Outlet, Inc441d049c-8844-955e-e063-6294a90a666d2026-05-21WarningsExact identifier
unii: 64O047KTOA
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Cetrizine HydrochlorideCETIRIZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC9c0549cf-4c93-45d9-9eac-3948fa45554e2026-05-18WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCa57a0dbe-0926-4b25-a5d7-b8d499d671582026-05-18WarningsExact identifier
unii: 64O047KTOA
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine HClCETIRIZINE HCLAMERISOURCE BERGEN518ed897-7365-0520-e063-6394a90a06d62026-05-11WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLTOP CARE (Topco Associates LLC)3363bd32-cac6-e10c-e063-6294a90a26382026-05-11WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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