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 105 of 129 · 2,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.711aa92c-81b0-42e4-b83f-9ce95116ec032024-02-16WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
unii: 15FIX9V2JP
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
unii: 15FIX9V2JP
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
unii: 15FIX9V2JP
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
unii: 15FIX9V2JP
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
Wal-Zyr DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company778ba62e-6cce-4d0f-b6d9-48b35ef40da72024-01-25WarningsExact identifier
unii: 64O047KTOA
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsExact identifier
unii: 64O047KTOA
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
Visine Red Eye Hydrating Comfort, CVPTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPSLil' Drug Store Products, Inc.0f50bcc8-3658-8c2c-e063-6294a90a8e132024-01-19WarningsExact identifier
unii: B697894SGQ
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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