FDA.reportPublic FDA data

Allergy Relief D

Product NDC
11822-1055
11-digit product format
118221055
Labeler code
11822
Product ID
11822-1055_b4843b45-f5a7-4ad9-ae84-b59b4c3e718f
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, Pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076050
Marketing category
ANDA
Marketing start
2020-05-05
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1
PSEUDOEPHEDRINE SULFATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN, Y9DL7QPE6B
Rxcui1242399

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1055-0Allergy Relief D10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE105
11822-1055-0Allergy Relief D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
11822-1055-1Allergy Relief D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
11822-1055-1Allergy Relief D30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE305
11822-1055-2Allergy Relief D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
11822-1055-2Allergy Relief D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1055ALLERGY RELIEF D (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RITE AID CORPORATION]5Current NDC, Legacy NDC, 6 package rows20240217_f08ebf00-a1d7-4a6f-a84f-195d000de53d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSNf08ebf00-a1d7-4a6f-a84f-195d000de53d5
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCDf08ebf00-a1d7-4a6f-a84f-195d000de53d5
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSYf08ebf00-a1d7-4a6f-a84f-195d000de53d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1055-01182210550010 BLISTER PACK in 1 CARTON (11822-1055-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2020-05-050000-00-00NoNoCurrent
11822-1055-11182210550130 BLISTER PACK in 1 CARTON (11822-1055-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2022-12-21NoNoCurrent
11822-1055-21182210550220 BLISTER PACK in 1 CARTON (11822-1055-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2023-06-21NoNoCurrent