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equate allergy relief

Loratadine · Tablet

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
equate allergy relief
Generic name
Loratadine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Wal-Mart Stores Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
8
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Diphenhydramine Hydrochloride 25 mg/1 1049630 View
Fexofenadine Hydrochloride 180 mg/1 997501 View
Loratadine 10 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
11

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076301
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 25, 2004
Sponsor
PERRIGO
Products on application
1
Submissions recorded
3
Products approved under application 076301.
Product Trade name Form Strength Ingredient Status TE Flags
076301-001 LORATADINE TABLET LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076301.
Type No. Action Status Date Review
Supplement 25 Labeling Approved September 23, 2011 —
Supplement 21 Labeling Approved March 20, 2009 —
Original application 1 Approved June 25, 2004 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260718). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260718 HUMAN OTC DRUG · 20250815 HUMAN OTC DRUG · 20221205

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily relieves these symptoms of the common cold: • runny nose • sneezing

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

Adverse event reports

Source: openFDA FAERS
172,003
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DIPHENHYDRAMINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
79903-297-10 79903-297 WALMART INC. 1 BOTTLE in 1 CARTON (79903-297-10) / 100 TABLET in 1 BOTTLE November 19, 2024
49035-612-46 49035-612 Wal-Mart Stores Inc 10 BLISTER PACK in 1 CARTON (49035-612-46) / 1 TABLET in 1 BLISTER PACK February 28, 2012
49035-612-72 49035-612 Wal-Mart Stores Inc 1 BOTTLE in 1 CARTON (49035-612-72) / 60 TABLET in 1 BOTTLE April 27, 2007
49035-612-87 49035-612 Wal-Mart Stores Inc 2 BOTTLE in 1 PACKAGE (49035-612-87) / 150 TABLET in 1 BOTTLE March 1, 2012
49035-612-95 49035-612 Wal-Mart Stores Inc 1 BOTTLE in 1 CARTON (49035-612-95) / 45 TABLET in 1 BOTTLE August 20, 2013
49035-366-02 49035-366 Walmart Inc. 1 BOTTLE in 1 CARTON (49035-366-02) / 120 TABLET in 1 BOTTLE April 14, 2011
49035-366-54 49035-366 Walmart Inc. 1 BOTTLE in 1 CARTON (49035-366-54) / 30 TABLET in 1 BOTTLE April 14, 2011
49035-366-59 49035-366 Walmart Inc. 2 BOTTLE in 1 CARTON (49035-366-59) / 30 TABLET in 1 BOTTLE April 14, 2011
79903-297 79903-297 WALMART INC. — November 19, 2024
49035-612 49035-612 Wal-Mart Stores Inc — April 27, 2007
49035-366 49035-366 Walmart Inc. — April 14, 2011

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.