FDA.reportPublic FDA data

NDC 70677-1279-01 - Cetirizine HCl

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
70677-1279
Requested NDC
70677-1279-01
Package NDCs from labels
70677-1279-2, 70677-1279-3, 70677-1279-4, 70677-1279-5, 70677-1279-1, 70677-1279-01
Manufacturer
Strategic Sourcing Services LLC | Glenmark Pharmaceuticals Limited
Effective date
2025-04-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine - Strategic Sourcing Services LLC | Glenmark Pharmaceuticals LimitedStrategic Sourcing Services LLC | Glenmark Pharmaceuticals Limited2025-04-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1279-1Cetirizine HCl14 in 1 BOTTLETABLET143
70677-1279-1Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-2Cetirizine HCl30 in 1 BOTTLETABLET303
70677-1279-2Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl60 in 1 BOTTLETABLET603
70677-1279-4Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-4Cetirizine HCl90 in 1 BOTTLETABLET903
70677-1279-5Cetirizine HCl300 in 1 BOTTLETABLET3003
70677-1279-5Cetirizine HCl1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1279CETIRIZINE HCL (CETIRIZINE) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 10 package rows20250406_65b37b00-8efc-4e04-ab97-a03e8af27d33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1279-1EA - Each70677-127963246e3e-43d7-4378-98dd-078c5443cc7d12025-05-14
70677-1279-2EA - Each70677-1279eb504316-ffda-49c2-8db3-b1e1855fe4b612025-05-14
70677-1279-3EA - Each70677-12792e39a72d-e107-4a01-b0ba-1bdc100a49b512025-05-14
70677-1279-4EA - Each70677-1279853f8a6b-588b-4a74-8561-6519d131827312025-05-14
70677-1279-5EA - Each70677-1279674b3c93-67e0-4d42-b057-8eaeefde5ad212025-05-14

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 4 of 153 · 3,050 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
Cetirizine HClCETIRIZINEGLENMARK THERAPEUTICS INC., USA04b08c52-5390-4cdb-a9e7-fca81fffdc732026-08-07WarningsExact identifier
application number: ANDA078427
rxcui: 1014678
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 64O047KTOA
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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