Allergy Relief

Product NDC
21130-195
Requested package NDC
21130-195-02
11-digit product format
211300195
Labeler code
21130
Product ID
21130-195_34053585-d72f-e039-e063-6294a90a6d4e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Safeway
Application
ANDA206214
Marketing category
ANDA
Marketing start
2019-10-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A206214-001LORATADINELORATADINE10MGCAPSULE / ORAL2016-09-23

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 22:54:322026-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINECVS HEALTH CORP899800a7-89bc-4a39-88b0-f19d78934daf2026-03-26WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINEKROGER COMPANY0599cc64-419d-452f-ac50-ac03110067292025-12-29WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
Allergy ReliefLORATADINESafeway8a1b3d40-8ec4-7e76-e053-2a95a90a84b12025-04-30WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
ndc (package): 21130-195-02
ndc (product): 21130-195
ndc11 (package): 21130019502
ALLERGY RELIEFLORATADINETARGET CORPORATION7cb1364b-0852-3444-e053-2991aa0a36292025-02-01WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
Allergy ReliefLORATADINECHAIN DRUG MARKETING ASSOCIATION, INC.e0cb8057-4755-482d-84f4-9275f7b85cd02024-08-12WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
WAL-ITINLORATADINEWALGREENS9e155aae-4735-4aab-bda9-c21ea29529a42022-11-11WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LoratadineLORATADINEMARKSANS PHARMA LIMITEDc30907f9-1761-41e5-bd4e-2613e756e1c62021-11-15WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINESMART SENSE (KMART)c2db3398-ead6-4bb6-8aa6-f1366a8461442018-05-16WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINETIME CAP LABORATORIES INC85b26cf3-448c-4d4f-93a2-aa89530ec1f12018-05-16WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214

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
828269Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a1b3d40-8ec4-7e76-e053-2a95a90a84b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-195-02Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14
21130-195-02Allergy Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-195ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [SAFEWAY]4Current NDC, Legacy NDC, 2 package rows20250502_8a1b3d40-8ec4-7e76-e053-2a95a90a84b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN8a1b3d40-8ec4-7e76-e053-2a95a90a84b14
828269loratadine 10 MG Oral CapsuleSCD8a1b3d40-8ec4-7e76-e053-2a95a90a84b14
828269loratadine 10 MG 24HR Oral CapsuleSY8a1b3d40-8ec4-7e76-e053-2a95a90a84b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-195-02211300195021 BLISTER PACK in 1 CARTON (21130-195-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-10-010000-00-00NoNoCurrent