topcare all day allergy

Generic: cetirizine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare all day allergy
Generic Name cetirizine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-458
Product ID 36800-458_dc4e4803-536c-4a2b-9faa-e307a66eb91a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2008-01-10

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800458
Hyphenated Format 36800-458

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 topcare all day allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-458-47) / 150 TABLET, FILM COATED in 1 BOTTLE
  • 14 BLISTER PACK in 1 CARTON (36800-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (36800-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (7)

36800-458-39 1 BOTTLE in 1 CARTON (36800-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE 36800-458-47 1 BOTTLE in 1 CARTON (36800-458-47) / 150 TABLET, FILM COATED in 1 BOTTLE 36800-458-66 14 BLISTER PACK in 1 CARTON (36800-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK 36800-458-72 1 BOTTLE in 1 CARTON (36800-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE 36800-458-75 1 BOTTLE in 1 CARTON (36800-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE 36800-458-87 1 BOTTLE in 1 CARTON (36800-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE 36800-458-95 1 BOTTLE in 1 CARTON (36800-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

TopCare All Day Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dc4e4803-536c-4a2b-9faa-e307a66eb91a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["f2919aad-9ed4-40b8-b233-4aec06df33ea"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-39)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-39", "marketing_start_date": "20090416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-47)  / 150 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-47", "marketing_start_date": "20100526"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (36800-458-66)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-458-66", "marketing_start_date": "20080110"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-72)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-72", "marketing_start_date": "20080128"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-75)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-75", "marketing_start_date": "20080919"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-87)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-87", "marketing_start_date": "20100428"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-458-95)  / 45 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-458-95", "marketing_start_date": "20090908"}], "brand_name": "TopCare All Day Allergy", "product_id": "36800-458_dc4e4803-536c-4a2b-9faa-e307a66eb91a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-458", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare All Day Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20080110", "listing_expiration_date": "20261231"}