FDA.reportPublic FDA data

NDC 70000-0213-03 - Leader Allergy Relief

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
70000-0213
Requested NDC
70000-0213-03
Package NDCs from labels
70000-0213-2, 70000-0213-3, 70000-0213-4, 70000-0213-1, 70000-0213-5, 70000-0213-6, 70000-0213-7, 70000-0213-03
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Allergy Relief - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-04-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0213-1Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-1Leader Allergy Relief10 in 1 CARTONTABLET106
70000-0213-2Leader Allergy Relief30 in 1 CARTONTABLET306
70000-0213-2Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-3Leader Allergy Relief70 in 1 BOTTLETABLET706
70000-0213-3Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-4Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-4Leader Allergy Relief90 in 1 BOTTLETABLET906
70000-0213-5Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-5Leader Allergy Relief40 in 1 CARTONTABLET406
70000-0213-6Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-6Leader Allergy Relief300 in 1 BOTTLETABLET3006
70000-0213-7Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-7Leader Allergy Relief100 in 1 BOTTLETABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0213LEADER ALLERGY RELIEF (LORATADINE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER]6Current NDC, Legacy NDC, 14 package rows20250403_6f5134c6-ece6-4e35-a0c3-13e0dfa173fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0213-1EA - Each70000-0213280b30f0-4942-4116-bf61-e1e1bc2163ca12017-11-06
70000-0213-2EA - Each70000-02134174a45f-ef34-487d-b9bf-1e702d79252112017-11-06
70000-0213-3EA - Each70000-0213463d9a05-fd01-42db-8da7-eaeaab22f77b12017-11-06
70000-0213-4EA - Each70000-0213f2f06829-87f9-4f02-93c3-50448d007a7e12017-11-06
70000-0213-5EA - Each70000-0213504c440b-543f-4806-89ab-d5c035ff038212018-08-13
70000-0213-6EA - Each70000-021335c7fb4b-4abb-414b-8f70-32c818608a3912020-06-05

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 1 of 24 · 466 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATERite Aid Corporationf08ebf00-a1d7-4a6f-a84f-195d000de53d2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
loratadineLORATADINERite Aid Corporation7b804f66-9323-4119-a856-1e6f082807812026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEYYBA CORP5a71de5c-a844-9dd4-e063-6294a90af0152026-09-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172026-08-30WarningsExact identifier
unii: 7AJO3BO7QN
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-08-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
childrens allergy reliefLORATADINEAmazon.com Services LLC74bc9e66-2bd0-457f-b2c4-5b4c6a1e689c2026-08-20WarningsExact identifier
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
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
LoratadineLORATADINEMajor Pharmaceuticals98e41ae1-677a-4583-9a0a-edba29ebbc302026-08-07WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine ODTLORATADINERugby Laboratoriesf59f3400-da77-4eb7-be02-842071d87fae2026-08-07WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INC2e75a831-eccc-4179-a4e3-9844be24bcda2026-08-05WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INCaf6e6e60-8e39-45a8-bb76-50403aef96682026-08-04WarningsExact identifier
unii: 7AJO3BO7QN
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
rxcui: 311372
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
application number: ANDA076301
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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