FDA.reportPublic FDA data

NDC 41167-3535-01 - Childrens Xyzal Allergy

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
41167-3535
Requested NDC
41167-3535-01
Package NDCs from labels
41167-3535-0, 41167-3535-1, 41167-3535-01
Manufacturer
Chattem, Inc.
Effective date
2026-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Xyzal AllergyChattem, Inc.2026-02-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-3535-0Childrens Xyzal Allergy1 in 1 CARTONSOLUTION122
41167-3535-0Childrens Xyzal Allergy148 mL in 1 BOTTLESOLUTION14822
41167-3535-1Childrens Xyzal Allergy296 mL in 1 BOTTLESOLUTION29622
41167-3535-1Childrens Xyzal Allergy1 in 1 CARTONSOLUTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-3535CHILDRENS XYZAL ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) SOLUTION [CHATTEM, INC.]18Current NDC, 4 package rows20250228_a33f2704-d350-428b-b467-91f4775ce17f.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 6 of 31 · 618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Childrens Xyzal AllergyLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.a33f2704-d350-428b-b467-91f4775ce17f2026-02-05WarningsExact identifier
application number: NDA209090
ndc (package): 41167-3535-1
ndc (package): 41167-3533-0
ndc (package): 41167-3535-0
ndc (package): 41167-3533-1
ndc (package): 41167-3530-1
ndc (product): 41167-3535
ndc (product): 41167-3533
ndc (product): 41167-3530
ndc11 (package): 41167353501
rxcui: 855168
rxcui: 855170
spl id: 3ce97c09-ae27-48cf-9413-0c7190a1fb94
spl set id: a33f2704-d350-428b-b467-91f4775ce17f
unii: SOD6A38AGA
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
FUNGAL NAIL TREATMENTFUNGAL NAIL TREATMENTJiangxi He-Oumei Health Industry Co., Ltd.4922f627-167a-1783-e063-6394a90acd6f2026-01-24WarningsExact identifier
unii: Q40Q9N063P
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEKROGER COMPANYe47658af-e0f3-5765-f568-300ba407dc292026-01-20WarningsExact identifier
unii: SOD6A38AGA
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECVS PHARMACYc8681ca3-27b4-6738-af72-599ff05f2ec82026-01-20WarningsExact identifier
unii: SOD6A38AGA
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalgreens Company766b8836-74b8-8af7-b900-b813b4fc175b2026-01-20WarningsExact identifier
unii: SOD6A38AGA
24HR Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDELEADER/ Cardinal Health 110, Inc.6ba57f12-fd25-c4a6-ff2d-2955116f84c42026-01-20WarningsExact identifier
unii: SOD6A38AGA
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAlbertsons Companiese1a6932b-d076-6573-5b88-7b06c3a916812026-01-20WarningsExact identifier
unii: SOD6A38AGA

Reported adverse events (FAERS/openFDA)#

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