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 45 of 130 · 2,596 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
unii: 15FIX9V2JP
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
unii: 15FIX9V2JP
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mattifying Skin PrimerTITANIUM DIOXIDE, ZINC OXIDESKIN MAVEN37662032-2842-1982-e063-6294a90a49a02025-12-15Exact identifier
unii: 15FIX9V2JP
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact identifier
unii: 15FIX9V2JP
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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