FDA.reportPublic FDA data

NDC 0904-6074-89 - Loratadine

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
0904-6074
Requested NDC
0904-6074-89
Package NDCs from labels
0904-6074-46, 0904-6074-60, 0904-6074-61, 0904-6074-89
Manufacturer
Major Pharmaceuticals
Effective date
2020-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - Major PharmaceuticalsMajor Pharmaceuticals2020-01-29HUMAN OTC DRUG LABEL
Loratadine - Major PharmaceuticalsMajor Pharmaceuticals2016-11-03HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6074-46EA - Each0904-60745e9647fe-a1cb-4ea0-9f31-8a38bc8e039612013-02-13
0904-6074-60EA - Each0904-6074350ce3a8-a5c9-4532-baca-588e017ede0b12013-02-13
0904-6074-61EA - Each0904-6074d3d9f1fa-bdaa-4a48-903a-79fcc2ef771d12012-07-24
0904-6074-89EA - Each0904-60747e5b4c30-eb45-4f8d-8ec7-c918b9f80b0d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [MAJOR PHARMACEUTICALS]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [MAJOR PHARMACEUTICALS]1

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 21 · 405 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2026-09-29WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact 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
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
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
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
rxcui: 311372
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
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINEMeijer, Inc.190ecdc3-454a-4623-9e4a-09f4ab8650842026-07-09WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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