FDA.reportPublic FDA data

NDC 63868-964-73 - Cetirizine Hydrochloride and Pseudoephedrine 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
63868-964
Requested NDC
63868-964-73
Package NDCs from labels
63868-964-73, 63868-964-24
Manufacturer
Chain Drug Marketing Association, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2016-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CETIRIZINE HYDROCHLORIDE - Chain Drug Marketing Association, Inc. | Sun Pharmaceutical Industries LimitedChain Drug Marketing Association, Inc. | Sun Pharmaceutical Industries Limited2016-06-29Human OTC Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-964-242020-01-31C16284748780-19d75b9d0-6d75-f424-e053-dadaa90a57ceCetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-964-24Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE42
63868-964-73Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-964CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Legacy NDC, 2 package rows20160629_b83d0d38-442c-41ee-88c3-51690edbcd91.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 5 of 170 · 3,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
unii: 64O047KTOA
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
unii: ND2M416302
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
unii: ND2M416302
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
unii: ND2M416302
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
unii: 64O047KTOA
foster and thrive mucus relief dGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC12460719-ff39-49b3-95f8-85e547ad00762026-08-04WarningsExact identifier
unii: 6V9V2RYJ8N
Tazza Antiseptic Hand WipesISOPROPYL ALCOHOLTazza Brands East Inc.c37c7599-58b6-58bb-e053-2a95a90af1cf2026-08-04WarningsExact identifier
unii: ND2M416302
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsExact identifier
unii: 64O047KTOA
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
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
LEADER 12HR ALLERGY AND CONGESTION RELIEFFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader1400014a-2fa6-4a4f-8eb9-85ac049b4b702026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
rxcui: 1014571
unii: 64O047KTOA
unii: 6V9V2RYJ8N
EQUATE ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.6daeb739-a112-4a37-abbb-0bbc41b42df32026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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