FDA.reportPublic FDA data

NDC 68071-1964-04 - 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
68071-1964
Requested NDC
68071-1964-04
Package NDCs from labels
68071-1964-1, 68071-1964-3, 68071-1964-9, 68071-1964-7, 68071-1964-4, 68071-1964-04
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine Hydrochloride Tablets, 10 mg, AllergyNuCare Pharmaceuticals, Inc.2026-08-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-1964-12024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92024-07-15Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92023-01-30Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-04-16Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-12021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-32021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-72021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy
68071-1964-92021-01-29Cetirizine Hydrochloride Tablets, 10 mg, Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1964-1Cetirizine Hydrochloride10 in 1 BOTTLETABLET105
68071-1964-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET305
68071-1964-7Cetirizine Hydrochloride7 in 1 BOTTLETABLET75
68071-1964-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1964CETIRIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240716_4913192a-7364-3f19-e054-00144ff8d46c.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 2 of 127 · 2,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.44410d76-5940-4611-be45-579e2db8a65d2026-08-24WarningsExact identifier
application number: ANDA077829
rxcui: 1014678
unii: 64O047KTOA
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
application number: ANDA077829
ndc (package): 68071-1964-3
ndc (package): 68071-1964-7
ndc (package): 68071-1964-9
ndc (package): 68071-1964-4
ndc (package): 68071-1964-1
ndc (product): 68071-1964
ndc11 (package): 68071196404
rxcui: 1014678
spl id: 597fa840-d201-db80-e063-6294a90afcb7
spl set id: 4913192a-7364-3f19-e054-00144ff8d46c
unii: 64O047KTOA
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsExact identifier
unii: 64O047KTOA
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsExact identifier
unii: 64O047KTOA
allergy relief childrensCETIRIZINE HCLCVS Pharmacy1a20acb5-207f-4499-a4c3-8733454555382026-08-13WarningsExact identifier
unii: 64O047KTOA
Childrens Allergy ReliefCETIRIZINE HCLCVS Pharmacy0210f9e5-c35b-4cfa-92d1-48555e99f1f32026-08-13WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLC29bac87e-8559-47be-838d-c00e57f9f7ba2026-08-12WarningsExact identifier
unii: 64O047KTOA
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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