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All Day 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
All Day Allergy Relief
Generic name
Loratadine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
12
Packages
22
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cetirizine Hydrochloride 10 mg/1 1014678 View
Loratadine 10 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
34

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
075209
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 21, 2003
Sponsor
PLD ACQUISITIONS LLC
Products on application
1
Submissions recorded
4
Products approved under application 075209.
Product Trade name Form Strength Ingredient Status TE Flags
075209-001 LORATADINE TABLET LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 075209.
Type No. Action Status Date Review
Supplement 19 Manufacturing (CMC) Approved March 10, 2010 —
Supplement 18 Labeling Approved March 20, 2009 —
Supplement 2 Labeling Approved October 29, 2003 —
Original application 1 Approved January 21, 2003 —

Review documents

  • 0 · Original application · July 24, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260223). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260223 HUMAN OTC DRUG · 20231215 HUMAN OTC DRUG · 20231026

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 6 years and over Take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222) right away.

Do Not Use

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients, or to an antihistamine containing hydroxyzine.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

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) Loratadine, USP 10 mg

Adverse event reports

Source: openFDA FAERS
166,303
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: CETIRIZINE 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
55910-269-58 55910-269 DOLGENCORP, INC. 1 BOTTLE in 1 CARTON (55910-269-58) / 45 TABLET in 1 BOTTLE December 20, 2023
55910-039-45 55910-039 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-039-45) / 45 TABLET in 1 BOTTLE, PLASTIC July 1, 2019
55910-718-30 55910-718 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-718-30) / 30 TABLET in 1 BOTTLE, PLASTIC October 25, 2023
55910-718-60 55910-718 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-718-60) / 60 TABLET in 1 BOTTLE, PLASTIC October 25, 2023
55910-985-30 55910-985 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-985-30) / 30 TABLET in 1 BOTTLE, PLASTIC October 1, 2023
55319-938-10 55319-938 Family Dollar (FAMILY WELLNESS) 10 BLISTER PACK in 1 CARTON (55319-938-10) / 1 TABLET in 1 BLISTER PACK August 31, 2023
55319-938-30 55319-938 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-938-30) / 30 TABLET in 1 BOTTLE, PLASTIC August 31, 2023
59726-806-05 59726-806 P & L Development, LLC 5 BLISTER PACK in 1 CARTON (59726-806-05) / 1 TABLET in 1 BLISTER PACK June 30, 2018
59726-806-14 59726-806 P & L Development, LLC 14 BLISTER PACK in 1 CARTON (59726-806-14) / 1 TABLET in 1 BLISTER PACK June 30, 2018
83324-146-30 83324-146 QUALITY CHOICE (Chain Drug Marketing Association) 1 BOTTLE, PLASTIC in 1 BOX (83324-146-30) / 30 TABLET in 1 BOTTLE, PLASTIC July 31, 2024
83324-147-10 83324-147 QUALITY CHOICE (Chain Drug Marketing Association) 10 BLISTER PACK in 1 CARTON (83324-147-10) / 1 TABLET in 1 BLISTER PACK July 31, 2024
21130-914-10 21130-914 Safeway, Inc. 10 BLISTER PACK in 1 CARTON (21130-914-10) / 1 TABLET in 1 BLISTER PACK March 31, 2023
21130-914-12 21130-914 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-914-12) / 120 TABLET in 1 BOTTLE, PLASTIC March 31, 2023
21130-914-60 21130-914 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-914-60) / 60 TABLET in 1 BOTTLE, PLASTIC March 31, 2023
70677-0057-1 70677-0057 Strategic Sourcing Services LLC 14 BLISTER PACK in 1 CARTON (70677-0057-1) / 1 TABLET in 1 BLISTER PACK August 31, 2018
79903-156-10 79903-156 WALMART INC. (see also Equate) 10 BLISTER PACK in 1 CARTON (79903-156-10) / 1 TABLET in 1 BLISTER PACK November 30, 2022
79903-156-12 79903-156 WALMART INC. (see also Equate) 2 BOTTLE, PLASTIC in 1 BOX (79903-156-12) / 60 TABLET in 1 BOTTLE, PLASTIC November 30, 2022
79903-156-45 79903-156 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-156-45) / 45 TABLET in 1 BOTTLE, PLASTIC November 30, 2022
79903-156-60 79903-156 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-156-60) / 60 TABLET in 1 BOTTLE, PLASTIC November 30, 2022
79903-156-99 79903-156 WALMART INC. (see also Equate) 2 BOTTLE, PLASTIC in 1 BOX (79903-156-99) / 150 TABLET in 1 BOTTLE, PLASTIC November 30, 2022
79903-437-12 79903-437 WALMART INC. (see also Equate) 120 TABLET in 1 BOTTLE, PLASTIC (79903-437-12) April 1, 2026
79903-437-36 79903-437 WALMART INC. (see also Equate) 365 TABLET in 1 BOTTLE, PLASTIC (79903-437-36) April 1, 2026
55910-269 55910-269 DOLGENCORP, INC. — December 20, 2023
55910-039 55910-039 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — July 1, 2019
55910-718 55910-718 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — October 25, 2023
55910-985 55910-985 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — October 1, 2023
55319-938 55319-938 Family Dollar (FAMILY WELLNESS) — August 31, 2023
59726-806 59726-806 P & L Development, LLC — June 30, 2018
83324-146 83324-146 QUALITY CHOICE (Chain Drug Marketing Association) — July 31, 2024
83324-147 83324-147 QUALITY CHOICE (Chain Drug Marketing Association) — July 31, 2024
21130-914 21130-914 Safeway, Inc. — March 31, 2023
70677-0057 70677-0057 Strategic Sourcing Services LLC — August 31, 2018
79903-156 79903-156 WALMART INC. (see also Equate) — November 30, 2022
79903-437 79903-437 WALMART INC. (see also Equate) — April 1, 2026

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.