FDA.reportPublic FDA data

Allergy Relief

Product NDC
69168-309
11-digit product format
691680309
Labeler code
69168
Product ID
69168-309_520a7a7c-a1a5-48a6-b472-9d47a4463452
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA076471
Marketing category
ANDA
Marketing start
2014-12-16
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69168-30969168-309-10DDiscontinued by firm2026-08-03
excluded packagepackage69168-30969168-309-30DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076471-001LORATADINELORATADINE10MGTABLET / ORAL2006-02-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076471-001LORATADINE10MGTABLET / ORAL2006-02-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEApotex Corp.679164cc-7505-7ed4-13fe-87f06cb777d82025-09-22WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.031fc3e5-b5eb-447c-e063-6294a90a13b52023-08-17WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
Allergy ReliefLORATADINEAllegiant Health0991388a-2eb8-4913-9efc-adf411eddf3a2018-11-08WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
ndc (product): 69168-309
AllergyLORATADINESelder, S.A. de C.V.afdb0117-dd2d-4ab1-a2f4-2a88b6bf52512016-12-22WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311372Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0991388a-2eb8-4913-9efc-adf411eddf3aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-309-082020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-092020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-102020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-302020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-082020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-092020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-102020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-302020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-309-03Allergy Relief30 in 1 BLISTER PACKTABLET306
69168-309-08Allergy Relief5 in 1 BLISTER PACKTABLET56
69168-309-08Allergy Relief1 in 1 CARTONTABLET16
69168-309-09Allergy Relief10 in 1 BLISTER PACKTABLET106
69168-309-09Allergy Relief1 in 1 CARTONTABLET16
69168-309-10Allergy Relief1000 in 1 BOTTLETABLET10006
69168-309-30Allergy Relief1 in 1 CARTONTABLET16
69168-309-30Allergy Relief30 in 1 BOTTLETABLET306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-309ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 8 package rows20241206_0991388a-2eb8-4913-9efc-adf411eddf3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0991388a-2eb8-4913-9efc-adf411eddf3a6
311372loratadine 10 MG Oral TabletSCD0991388a-2eb8-4913-9efc-adf411eddf3a6
311372loratadine 10 MG 24 HR Oral TabletSY0991388a-2eb8-4913-9efc-adf411eddf3a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-309-036916803090330 TABLET in 1 BLISTER PACK (69168-309-03) 30 tablet2014-12-16NoNoCurrent
69168-309-08691680309081 BLISTER PACK in 1 CARTON (69168-309-08) / 5 TABLET in 1 BLISTER PACK1 blister pack2014-12-160000-00-00NoNoCurrent
69168-309-09691680309091 BLISTER PACK in 1 CARTON (69168-309-09) / 10 TABLET in 1 BLISTER PACK1 blister pack2014-12-160000-00-00NoNoCurrent
69168-309-10691680309101000 TABLET in 1 BOTTLE (69168-309-10) 1000 tablet2014-12-160000-00-00NoNoCurrent
69168-309-30691680309301 BOTTLE in 1 CARTON (69168-309-30) > 30 TABLET in 1 BOTTLE1 bottle2014-12-160000-00-00NoNoCurrent