FDA.reportPublic FDA data

NDC 51672-2106-01 - 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
51672-2106
Requested NDC
51672-2106-01
Package NDCs from labels
51672-2106-8, 51672-2106-1, 51672-2106-4, 51672-2106-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's Cetirizine Hydrochloride Oral SolutionSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2106-1Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-1Cetirizine Hydrochloride240 mL in 1 BOTTLESOLUTION2406
51672-2106-4Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-4Cetirizine Hydrochloride60 mL in 1 BOTTLESOLUTION606
51672-2106-8Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-8Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2106CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20241211_67207357-5f8a-4424-9901-d2717a43cf1b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
acetic acidINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4

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 25 of 52 · 1,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.6d81446e-f713-4ca4-af38-3d31cf6188732025-08-01Adverse reactionsExact identifier
rxcui: 1014673
unii: 64O047KTOA
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC3b5908f1-faba-c317-e063-6294a90aa8a72025-08-01Adverse reactionsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Childrens 24 Hour AllergyCETIRIZINE HCLMeijer Distribution Inc4fba7f23-8123-4704-97a9-2c5d1e7e289a2025-07-30WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC2c1ecee3-c2c1-25a2-e063-6294a90aad542025-07-21WarningsExact identifier
unii: 64O047KTOA
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsExact identifier
unii: 64O047KTOA
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsExact identifier
unii: 64O047KTOA
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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