allergy relief d12 (51316-607)

Drug Facts

Product Profile

Brand Name allergy relief d12

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride

Labeler cvs woonsocket prescription center, incorporated

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 5 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-607

Product ID 51316-607_bce0bf03-5fc9-4944-b8ad-5400d0a4405a

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210719

Listing Expiration 2027-12-31

Marketing Start 2025-12-10

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316607

Hyphenated Format 51316-607

Supplemental Identifiers

RxCUI

1014571

UNII

64O047KTOA 6V9V2RYJ8N

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name allergy relief d12 (source: ndc)

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA210719 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
120 mg/1

source: ndc

Packaging

12 BLISTER PACK in 1 CARTON (51316-607-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
24 BLISTER PACK in 1 CARTON (51316-607-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

51316-607-53 12 BLISTER PACK in 1 CARTON (51316-607-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 51316-607-62 24 BLISTER PACK in 1 CARTON (51316-607-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

cetirizine hydrochloride (5 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

ALLERGY RELIEF D12 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "bce0bf03-5fc9-4944-b8ad-5400d0a4405a", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["5b6cd5ba-bdca-434e-b024-0089aeeec6a1"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (51316-607-53)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-607-53", "marketing_start_date": "20260220"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (51316-607-62)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-607-62", "marketing_start_date": "20251210"}], "brand_name": "ALLERGY RELIEF D12", "product_id": "51316-607_bce0bf03-5fc9-4944-b8ad-5400d0a4405a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "51316-607", "generic_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ALLERGY RELIEF D12", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA210719", "marketing_category": "ANDA", "marketing_start_date": "20251210", "listing_expiration_date": "20271231"}