FDA.reportPublic FDA data

NDC 70677-1007-04 - 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
70677-1007
Requested NDC
70677-1007-04
Package NDCs from labels
70677-1007-3, 70677-1007-1, 70677-1007-2, 70677-1007-4, 70677-1007-04
Manufacturer
Strategic Sourcing Services LLC
Effective date
2025-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine Hydrochloride Tablets - Strategic Sourcing Services LLCStrategic Sourcing Services LLC2025-07-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1007-1cetirizine hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
70677-1007-1cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-2cetirizine hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
70677-1007-2cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-3cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-3cetirizine hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
70677-1007-4cetirizine hydrochloride300 in 1 BOTTLETABLET, FILM COATED3003
70677-1007-4cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1007CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 8 package rows20230422_52b70885-f623-b1c8-29c6-584bff46ed45.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1007-1EA - Each70677-1007b030d00d-b5a2-41f3-b8d9-69b9d5fe096412023-09-05
70677-1007-2EA - Each70677-1007f5b098e3-a1e4-4d49-b3f7-1adfe8889e6812023-09-05
70677-1007-3EA - Each70677-1007f68a27ec-df80-442a-948e-f5887ac0103012023-09-05
70677-1007-4EA - Each70677-1007c77cd805-0611-4779-b839-da528a00ac8712023-09-05

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 97 of 129 · 2,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
unii: 15FIX9V2JP
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEH.E.B.c5279caf-3af9-d163-e053-2995a90a943b2024-10-15WarningsExact identifier
unii: 15FIX9V2JP
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
unii: 15FIX9V2JP
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
unii: 15FIX9V2JP
Allergy ReliefCETIRIZINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.4f2d0a71-fda5-435a-a220-3292cd74a42a2024-10-11WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
unii: 15FIX9V2JP
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEIndoco Remedies Limited2942e093-5077-44d3-b080-8d945d03c55f2024-10-07WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLPUBLIX SUPER MARKETS INC1ab5c526-b5fd-fca0-e063-6294a90ac54a2024-10-03WarningsExact identifier
unii: 64O047KTOA
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC97997887-9cba-48f8-abcd-fdb86829459c2024-10-03WarningsExact identifier
unii: 64O047KTOA
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
Members Mark Childrens CetirizineCETIRIZINE HYDROCHLORIDESam's West Inc9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2024-09-25WarningsExact identifier
unii: 64O047KTOA
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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