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 7 of 169 · 3,379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsExact identifier
unii: 64O047KTOA
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
unii: ND2M416302
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEKROGER COMPANYb92d959d-dd35-b2a3-e053-2995a90af3ff2026-07-15WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.67207357-5f8a-4424-9901-d2717a43cf1b2026-07-14WarningsExact identifier
unii: 64O047KTOA
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESelect Consumer Group568960cf-2c8f-f1b0-e063-6294a90aebc72026-07-13WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)CETIRIZINE HYDROCHLORIDEMARKSANS PHARMA LIMITED652b0c65-a3f2-4454-9cf2-51a3389282cc2026-07-10WarningsExact identifier
unii: 64O047KTOA
Alcohol Cleansing WipeISOPROPYL ALCOHOLHubei Fanjian Medical Product Co.,Ltd1607fb06-826b-42bb-986e-0023a1b078f32026-07-10WarningsExact identifier
unii: ND2M416302
RUGBY ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories35f93439-eed1-40f4-a792-7527fbf3c19a2026-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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