FDA.reportPublic FDA data

kirkland signature aller tec d

Product NDC
63981-147
11-digit product format
639810147
Labeler code
63981
Product ID
63981-147_597ad0d6-abb0-47c1-b9f6-bc37e2968a69
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-03-30
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16

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 22:54:322026-06A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16a50c72e98297…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy relief-DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporationfdf98201-661c-4b1e-97f6-265807d90f762026-05-27WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyaa515879-9851-4915-bd41-51d81e585dd72026-02-28WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
ALLERGY RELIEF D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5b6cd5ba-bdca-434e-b024-0089aeeec6a12026-02-17WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Allergy and Sinus ReliefCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company28d3aee3-52fb-4e87-a6f2-4634f1770a702026-01-19WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
FOSTER AND THRIVE ALL DAY ALLERGY DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC796bea75-847a-40cd-892c-0905caae5c4e2025-12-10WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
All Day Allergy DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyb38cb1c8-3575-4283-8692-00cd4cd8d5cc2025-10-02WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
12 hour allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Incb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e772025-06-19WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc821c3880-303d-470a-af6a-e13be7ab313f2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd3260111b-35da-4f95-8081-51eae4b1ef452025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
topcare all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC103df878-1455-414f-94cb-5b32a2d3e4b82025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
equate allergy relief d nasal decongestantCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.7b7b8cce-ede6-47c6-91c8-88fd94cb292d2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company2f1df816-311b-444a-8040-21227016614b2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacyfe26cba3-5b84-462c-ac2b-e9e09612ad1d2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories5c6ac9a2-4f0a-4297-9b83-988d54598f752025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
signature care allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDESafeway8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c802025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEH E Bb3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bb2025-02-11WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
kirkland signature aller tec dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECostco Wholesale Companya8e57b21-4622-4315-8e8e-437243be2fe12025-02-04WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
ndc (product): 63981-147
good sense all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyc7154370-5d91-4dc4-90ed-1d07d9bc59432025-02-04WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
good neighbor pharmacy all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergena7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b2025-01-03WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Leader Allergy Relief DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader3152060c-f613-49db-91d4-356d2070c4662023-06-15WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719

Additional Listing Data#

Finished product
Yes
Brand name base
kirkland signature aller tec d
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014571Internal RxNorm lookup
1014573Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8e57b21-4622-4315-8e8e-437243be2fe1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
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
63981-147-62kirkland signature aller tec d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
63981-147-62kirkland signature aller tec d24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-147-62EA - Each63981-1478e460ce5-d1a8-46b1-95d2-25a85dc3c9d612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-147KIRKLAND SIGNATURE ALLER TEC D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [COSTCO WHOLESALE COMPANY]5Current NDC, Legacy NDC, 2 package rows20250216_a8e57b21-4622-4315-8e8e-437243be2fe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014573ALLER-TEC D ALLERGY & CONGESTION 5 MG / 120 MG 12HR Extended Release Oral TabletPSNa8e57b21-4622-4315-8e8e-437243be2fe15
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNa8e57b21-4622-4315-8e8e-437243be2fe15
101457312 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Aller-Tec D]SBDa8e57b21-4622-4315-8e8e-437243be2fe15
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDa8e57b21-4622-4315-8e8e-437243be2fe15
1014573Aller-Tec D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral TabletSYa8e57b21-4622-4315-8e8e-437243be2fe15
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYa8e57b21-4622-4315-8e8e-437243be2fe15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-147-626398101476224 BLISTER PACK in 1 CARTON (63981-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-03-300000-00-00NoNoCurrent