Allergy Relief

Product NDC
63941-193
Requested package NDC
63941-193-06
11-digit product format
639410193
Labeler code
63941
Product ID
63941-193_45b22960-9237-ca1d-e063-6294a90a37ce
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
2027-11-30
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
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
A210722-001LORATADINELORATADINE10MGTABLET / ORAL2019-12-23

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 22:54:322026-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a50c72e98297…

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINESt. Mary's Medical Park Pharmacy2bc586e4-5297-44cf-e063-6294a90a531d2026-06-29WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEPreferred Pharmaceuticals Inc.c6144a33-6b33-4aca-86e5-a3f688b8b3172026-05-28WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEGrocery Outlet, Inc441cfa86-a812-f67f-e063-6394a90a21182026-05-21WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEGRANULES USA, INC.c3c9bc45-7ed5-abf4-e053-2995a90a40ff2025-12-22WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINESafeway, Incf2a2a754-0170-e37c-e053-2a95a90a4dca2025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Loratadine 10mgLORATADINE 10MGMeijer181b7dd1-ddc4-e799-e063-6294a90a9faa2025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEWalgreensfd796139-ea9f-f4db-e053-6394a90acdf32025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEValu Merchandisers Company05927511-6b7a-4e29-96b4-3043493acf112025-12-11WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
ndc (package): 63941-193-06
ndc (product): 63941-193
ndc11 (package): 63941019306
CAREALL Allergy ReliefLORATADINENew World Imports4d15d926-9564-4bef-b8a9-768af7a0ab6a2025-12-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporationf98a45fd-cda8-4884-e053-6294a90a57b52025-11-21WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEWinCo Foods, LLC3dea627d-4b0c-e077-e063-6394a90a15a02025-11-03WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
McKesson LoratadineLORATADINE 10 MGMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
First Aid Direct Allergy ReliefLORATADINE TABLETSCintas Corporation6b43e5a5-30a8-46ca-a44d-1e1abf567b512025-09-23WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEGranules India Limited9bae1ba3-c0da-23a2-e053-2a95a90a58ed2025-08-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Curist Allergy ReliefLORATADINE 10 MGLittle Pharma, Inc.0c53cf0f-7682-a422-e063-6394a90ab7642025-06-15WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEBryant Ranch Prepack0d74af21-3ef7-418b-a2ef-78737b0af2882025-06-13WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief

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
05927511-6b7a-4e29-96b4-3043493acf11Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-193-04Allergy Relief1 in 1 CARTONTABLET13
63941-193-04Allergy Relief10 in 1 BLISTER PACKTABLET103
63941-193-06Allergy Relief30 in 1 BOTTLE, PLASTICTABLET303
63941-193-06Allergy Relief1 in 1 CARTONTABLET13
63941-193-09Allergy Relief60 in 1 BOTTLE, PLASTICTABLET603
63941-193-09Allergy Relief1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-193ALLERGY RELIEF (LORATADINE) TABLET [VALU MERCHANDISERS COMPANY]2Current NDC, Legacy NDC, 6 package rows20200912_05927511-6b7a-4e29-96b4-3043493acf11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN05927511-6b7a-4e29-96b4-3043493acf113
311372loratadine 10 MG Oral TabletSCD05927511-6b7a-4e29-96b4-3043493acf113
311372loratadine 10 MG 24 HR Oral TabletSY05927511-6b7a-4e29-96b4-3043493acf113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-193-06639410193061 BOTTLE, PLASTIC in 1 CARTON (63941-193-06) / 30 TABLET in 1 BOTTLE, PLASTIC2020-07-012027-11-30NoNoCurrent