FDA.reportPublic FDA data

NDC 70000-0504-01 - Leader Allergy Relief D12

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
70000-0504
Requested NDC
70000-0504-01
Package NDCs from labels
70000-0504-3, 70000-0504-2, 70000-0504-1, 70000-0504-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2021-06-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Allergy Relief D12 - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2021-06-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0504-1Leader Allergy Relief D121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
70000-0504-1Leader Allergy Relief D1210 in 1 CARTONTABLET, FILM COATED, EXTENDED RE103
70000-0504-2Leader Allergy Relief D121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
70000-0504-2Leader Allergy Relief D1220 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203
70000-0504-3Leader Allergy Relief D121 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
70000-0504-3Leader Allergy Relief D1230 in 1 CARTONTABLET, FILM COATED, EXTENDED RE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0504LEADER ALLERGY RELIEF D12 (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 6 package rows20210618_98bd6186-2bd2-4f46-99df-f509bb00e03a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0504-1EA - Each70000-0504a1395745-0a01-46ff-bc2b-0aca6091f6d912020-07-13
70000-0504-2EA - Each70000-050473c95d4a-ca70-463c-92cb-8b9785a278c512020-08-06
70000-0504-3EA - Each70000-0504a3217645-2e0b-4662-870a-8f0cf7ca599412020-07-13

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 3 of 126 · 2,517 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
unii: 7AJO3BO7QN
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
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 ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.12c8066a-3429-481e-b63a-7ea2b439a1702026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.96a76906-58ad-40cd-be27-4ea254e298c52026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals, Inc.569a35be-d653-181c-e063-6294a90a6eb92026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINEMeijer, Inc.190ecdc3-454a-4623-9e4a-09f4ab8650842026-07-09WarningsExact identifier
unii: 7AJO3BO7QN
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
allergy and nasal congestionLORATADINE, PSEUDOEPHEDRINE SULFATEKroger Company934dda74-7995-46f1-b6f2-f4b928a2eeb22026-07-08WarningsExact identifier
application number: ANDA076050
rxcui: 1242399
unii: Y9DL7QPE6B
unii: 7AJO3BO7QN
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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