FDA.reportPublic FDA data

NDC 68391-955-55 - levocetirizine dihydrochloride

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
68391-955
Requested NDC
68391-955-55
Package NDCs from labels
68391-955-55, 68391-955-11
Manufacturer
BJWC (Berkley & Jensen / BJ'S)
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
levocetirizine dihydrochloride - BJWC (Berkley & Jensen / BJ'S)BJWC (Berkley & Jensen / BJ'S)2025-12-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-955-11levocetirizine dihydrochloride2 in 1 PACKAGETABLET, COATED23
68391-955-55levocetirizine dihydrochloride55 in 1 BOTTLETABLET, COATED553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-955LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S) ]2Current NDC, 2 package rows20241020_0216f644-767c-ae88-f48f-cd29ac1547ed.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 54 of 133 · 2,648 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
unii: 15FIX9V2JP
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
unii: 15FIX9V2JP
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
unii: 15FIX9V2JP
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBJWC (Berkley & Jensen / BJ'S)0216f644-767c-ae88-f48f-cd29ac1547ed2025-12-10WarningsExact identifier
application number: ANDA210375
ndc (package): 68391-955-55
ndc (package): 68391-955-11
ndc (product): 68391-955
ndc11 (package): 68391095555
rxcui: 855172
spl id: 6098f8c4-4502-287f-cd05-06e17d773116
spl set id: 0216f644-767c-ae88-f48f-cd29ac1547ed
unii: SOD6A38AGA
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEChain Drug Marketing Association INC61fb8bef-d868-adee-3237-d3268d603ba62025-12-10WarningsExact identifier
application number: ANDA210375
rxcui: 855172
unii: SOD6A38AGA
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAMERISOURCEBERGEN DRUG CORPORATIONfdf54de3-16a9-3b28-b4c4-d745322b3d3c2025-12-10WarningsExact identifier
application number: ANDA210375
rxcui: 855172
unii: SOD6A38AGA
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI5036170d-7eeb-65a8-8473-7d98aeb51ee42025-12-10WarningsExact identifier
application number: ANDA210375
rxcui: 855172
unii: SOD6A38AGA
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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