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LORATADINE
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loratadine | 10 mg/1 | 311372 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206214-001 | LORATADINE | CAPSULE | LORATADINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | September 23, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241023). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
Purpose
openFDA Drug LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections Adults and children 6 years and over : 1 capsule daily; Not more than 1 capsule in 24 hours . Children under 6 years of age : ask a doctor. Consumers with liver or kidney disease : ask a doctor.
Warnings
openFDA Drug LabelingWarnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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.
Do Not Use
openFDA Drug LabelingDo not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have you have liver or kidney disease. Your doctor should determine if you need a different dose.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each capsule) Loratadine USP 10 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: LORATADINE. 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 58602-818-05 | 58602-818 | Aurohealth LLC | 5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 24, 2023 |
| 58602-818-08 | 58602-818 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 24, 2023 |
| 58602-818-67 | 58602-818 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 24, 2023 |
| 58602-818-83 | 58602-818 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 24, 2023 |
| 58602-818-84 | 58602-818 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 24, 2023 |
| 69452-211-03 | 69452-211 | Bionpharma Inc. | 1 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE | March 1, 2019 |
| 69452-211-07 | 69452-211 | Bionpharma Inc. | 1 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 1, 2019 |
| 69452-211-16 | 69452-211 | Bionpharma Inc. | 1 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE | March 1, 2019 |
| 69452-211-26 | 69452-211 | Bionpharma Inc. | 1 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE | March 1, 2019 |
| 69842-686-07 | 69842-686 | CVS HEALTH CORP | 1 BLISTER PACK in 1 CARTON (69842-686-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 31, 2017 |
| 69842-686-30 | 69842-686 | CVS HEALTH CORP | 3 BLISTER PACK in 1 CARTON (69842-686-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 31, 2017 |
| 69842-686-60 | 69842-686 | CVS HEALTH CORP | 6 BLISTER PACK in 1 CARTON (69842-686-60) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 31, 2017 |
| 61474-4268-1 | 61474-4268 | Catalent Ontario Limited | 2 BAG in 1 CARTON (61474-4268-1) / 10000 CAPSULE, LIQUID FILLED in 1 BAG | June 30, 2025 |
| 11014-0031-1 | 11014-0031 | Catalent Pharma Solutions, LLC | 1 BAG in 1 BOX (11014-0031-1) / 30000 CAPSULE, LIQUID FILLED in 1 BAG | June 16, 2008 |
| 41226-686-30 | 41226-686 | KROGER COMPANY | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-686-30) | April 26, 2017 |
| 25000-021-08 | 25000-021 | MARKSANS PHARMA LIMITED | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08) | October 1, 2016 |
| 25000-021-13 | 25000-021 | MARKSANS PHARMA LIMITED | 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13) | October 1, 2016 |
| 25000-021-21 | 25000-021 | MARKSANS PHARMA LIMITED | 4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG | October 1, 2016 |
| 25000-021-34 | 25000-021 | MARKSANS PHARMA LIMITED | 28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34) | October 1, 2016 |
| 25000-021-36 | 25000-021 | MARKSANS PHARMA LIMITED | 3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | October 17, 2020 |
| 25000-021-46 | 25000-021 | MARKSANS PHARMA LIMITED | 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46) | October 1, 2016 |
| 10888-8212-1 | 10888-8212 | Patheon Softgels Inc. | 22000 CAPSULE, LIQUID FILLED in 1 CASE (10888-8212-1) | March 12, 2020 |
| 49738-686-07 | 49738-686 | SMART SENSE (KMART) | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-07) | January 31, 2017 |
| 49738-686-30 | 49738-686 | SMART SENSE (KMART) | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-30) | January 31, 2017 |
| 49483-686-07 | 49483-686 | TIME CAP LABORATORIES INC | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07) | October 13, 2016 |
| 49483-686-30 | 49483-686 | TIME CAP LABORATORIES INC | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30) | October 13, 2016 |
| 58602-818 | 58602-818 | Aurohealth LLC | — | March 24, 2023 |
| 69452-211 | 69452-211 | Bionpharma Inc. | — | March 1, 2019 |
| 69452-283 | 69452-283 | Bionpharma Inc. | — | March 20, 2020 |
| 69842-686 | 69842-686 | CVS HEALTH CORP | — | January 31, 2017 |
| 61474-4268 | 61474-4268 | Catalent Ontario Limited | — | June 30, 2025 |
| 11014-0031 | 11014-0031 | Catalent Pharma Solutions, LLC | — | June 16, 2008 |
| 41226-686 | 41226-686 | KROGER COMPANY | — | April 26, 2017 |
| 25000-021 | 25000-021 | MARKSANS PHARMA LIMITED | — | October 1, 2016 |
| 10888-8212 | 10888-8212 | Patheon Softgels Inc. | — | March 12, 2020 |
| 49738-686 | 49738-686 | SMART SENSE (KMART) | — | January 31, 2017 |
| 49483-686 | 49483-686 | TIME CAP LABORATORIES INC | — | October 13, 2016 |
Sources for 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 · 10 sections on this page.