allergy relief

Generic: cetirizine hydrochloride

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name cetirizine hydrochloride
Labeler h e b
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-583
Product ID 37808-583_1a0c9fbb-a868-403b-9a25-76ee938ce754
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2018-01-26

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 37808583
Hyphenated Format 37808-583

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 allergy relief (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 (37808-583-06) / 70 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 14 BLISTER PACK in 1 CARTON (37808-583-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (37808-583-76) / 120 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (4)

37808-583-06 1 BOTTLE in 1 CARTON (37808-583-06) / 70 TABLET, FILM COATED in 1 BOTTLE 37808-583-39 1 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLE 37808-583-66 14 BLISTER PACK in 1 CARTON (37808-583-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK 37808-583-76 1 BOTTLE in 1 CARTON (37808-583-76) / 120 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

allergy relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a0c9fbb-a868-403b-9a25-76ee938ce754", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["8649fc1e-ad56-4660-bbbb-8f1ed795697b"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-583-06)  / 70 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "37808-583-06", "marketing_start_date": "20180126"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-583-39)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "37808-583-39", "marketing_start_date": "20180126"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (37808-583-66)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "37808-583-66", "marketing_start_date": "20180126"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-583-76)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "37808-583-76", "marketing_start_date": "20180126"}], "brand_name": "allergy relief", "product_id": "37808-583_1a0c9fbb-a868-403b-9a25-76ee938ce754", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37808-583", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "allergy relief", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}