FDA.reportPublic FDA data

kirkland signature allerclear d 12 hr

Product NDC
63981-723
11-digit product format
639810723
Labeler code
63981
Product ID
63981-723_24d75860-d636-416a-b89f-4b503c526802
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, Pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA076050
Marketing category
ANDA
Marketing start
2018-05-07
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

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
A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30

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 22:54:322026-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30a50c72e98297…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy and nasal congestionLORATADINE, PSEUDOEPHEDRINE SULFATEKroger Company934dda74-7995-46f1-b6f2-f4b928a2eeb22026-07-08WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company7e6ea563-cc79-4683-b600-0691e0fb78ab2026-04-09WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
allergy relief d 12LORATADINE, PSEUDOEPHEDRINE SULFATECVS Pharmacy0ca2b074-7137-478c-b32c-67f834f6c4542026-03-15WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATESportpharm LLCbb54f613-b2ab-48fd-83c9-2038ec7097f62026-02-06WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
good neighbor pharmacy loratadine dLORATADINE, PSEUDOEPHEDRINE SULFATEAmerisource Bergen90b0a155-b92c-45e3-959f-8f21065d31dd2025-09-12WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
equate allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATEWal-Mart Stores Inc306e8736-b27f-4445-b613-3e5b609f8d422025-07-17WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
foster and thrive allergy D 12 hourLORATADINE, PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLC4626e3ca-d3e9-46ad-9c53-66d27c82aed72025-06-13WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEMeijer Distribution Incdd19215c-0da7-483a-88e3-6a32ac210c4c2025-05-28WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
loratadine DLORATADINE, PSEUDOEPHEDRINE SULFATEPadagis Israel Pharmaceuticals Ltd01e61c73-3b81-4683-b1a9-8784c0d565b12025-03-03WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
Allergy and Congestion ReliefLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Companyb5589371-48bc-44a5-bcab-018a92e227962024-02-26WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATERite Aid Corporationf08ebf00-a1d7-4a6f-a84f-195d000de53d2024-02-16WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
kirkland signature allerclear d 12 hrLORATADINE, PSEUDOEPHEDRINE SULFATECostco Wholesale Company1534720b-f8f8-4db5-99e0-cfa49acf92992023-07-07WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
ndc (product): 63981-723
topcare allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATETopco Associates LLCdd93d172-2a3a-4e4c-a237-7668acbd537d2022-02-16WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
Alavert Allergy and Congestion D-12 hourLORATADINE AND PSEUDOEPHEDRINE SULFATEFoundation Consumer Brands1a669f3c-36a6-439e-843d-47638fa217e82021-12-07WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2021-10-08WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
Leader Allergy Relief D12LORATADINE, PSEUDOEPHEDRINE SULFATECardinal Health 110, LLC. dba Leader98bd6186-2bd2-4f46-99df-f509bb00e03a2021-06-17WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
signature care allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATESafewaye1993d05-248e-48da-838c-068f8263c2eb2021-03-08WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEPublix Super Markets Inc8209d7d5-4ecc-4170-ba50-5917bd8c46d42020-10-19WarningsExact identifier
application applno (ANDA): 076050
application number: ANDA076050

Additional Listing Data#

Finished product
Yes
Brand name base
kirkland signature allerclear d 12 hr
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup
Y9DL7QPE6BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1242399Internal RxNorm lookup
1369753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1534720b-f8f8-4db5-99e0-cfa49acf9299Available on FDA.report

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
63981-723-65kirkland signature allerclear d 12 hr30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE304
63981-723-65kirkland signature allerclear d 12 hr1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-723-65EA - Each63981-72304fae382-a322-42e0-8cff-f66fac39428612018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-723KIRKLAND SIGNATURE ALLERCLEAR D 12 HR (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [COSTCO WHOLESALE COMPANY]4Current NDC, Legacy NDC, 2 package rows20230719_1534720b-f8f8-4db5-99e0-cfa49acf9299.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369753AllerClear-D 5 MG / 120 MG 12HR Extended Release Oral TabletPSN1534720b-f8f8-4db5-99e0-cfa49acf92994
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSN1534720b-f8f8-4db5-99e0-cfa49acf92994
136975312 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Allerclear]SBD1534720b-f8f8-4db5-99e0-cfa49acf92994
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCD1534720b-f8f8-4db5-99e0-cfa49acf92994
1369753AllerClear (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral TabletSY1534720b-f8f8-4db5-99e0-cfa49acf92994
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSY1534720b-f8f8-4db5-99e0-cfa49acf92994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-723-656398107236530 BLISTER PACK in 1 CARTON (63981-723-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2018-05-070000-00-00NoNoCurrent