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DYE-FREE CHILDRENS LORATADINE

Loratadine · Tablet, Chewable

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
DYE-FREE CHILDRENS LORATADINE
Generic name
Loratadine
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
ANDA · ANDA
Labeler
CVS PHARMACY, INC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
14
Packages
18
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
Loratadine 5 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
32

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210088
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 16, 2018
Sponsor
SUN PHARM
Products on application
2
Submissions recorded
4
Products approved under application 210088.
Product Trade name Form Strength Ingredient Status TE Flags
210088-001 LORATADINE TABLET, CHEWABLE LORATADINE Over-the-counter —
210088-002 LORATADINE TABLET, CHEWABLE LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 210088.
Type No. Action Status Date Review
Supplement 15 Manufacturing (CMC) Approved April 25, 2025 Unknown
Supplement 12 Labeling Approved October 13, 2023 Standard
Supplement 7 Labeling Approved March 5, 2020 Standard
Original application 1 Approved April 16, 2018 Standard

Review documents

  • 0 · Original application · May 11, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240315). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240315 HUMAN OTC DRUG · 20220602 HUMAN OTC DRUG · 20210112

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 chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 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. 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 (1-800-222-1222).

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.

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 chewable tablet) Loratadine USP, 5 mg

Adverse event reports

Source: openFDA FAERS
114,194
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: 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
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
51316-821-20 51316-821 CVS PHARMACY, INC 2 BLISTER PACK in 1 CARTON (51316-821-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK March 15, 2024
51316-821-30 51316-821 CVS PHARMACY, INC 3 BLISTER PACK in 1 CARTON (51316-821-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK March 15, 2024
69842-894-30 69842-894 CVS PHARMACY, INC 3 BLISTER PACK in 1 CARTON (69842-894-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 17, 2020
69842-895-06 69842-895 CVS PHARMACY, INC 6 BLISTER PACK in 1 CARTON (69842-895-06) / 10 TABLET, CHEWABLE in 1 BLISTER PACK March 13, 2026
69842-895-20 69842-895 CVS PHARMACY, INC 2 BLISTER PACK in 1 CARTON (69842-895-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 17, 2020
69842-895-30 69842-895 CVS PHARMACY, INC 3 BLISTER PACK in 1 CARTON (69842-895-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 17, 2020
51660-112-31 51660-112 Ohm Laboratories Inc. 3 BLISTER PACK in 1 CARTON (51660-112-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 19, 2020
51660-726-30 51660-726 Ohm Laboratories Inc. 3 BLISTER PACK in 1 CARTON (51660-726-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK March 15, 2024
51660-726-61 51660-726 Ohm Laboratories Inc. 6 BLISTER PACK in 1 CARTON (51660-726-61) / 10 TABLET, CHEWABLE in 1 BLISTER PACK October 18, 2024
56062-900-20 56062-900 PUBLIX SUPER MARKETS, INC 2 BLISTER PACK in 1 CARTON (56062-900-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 1, 2020
56062-921-20 56062-921 PUBLIX SUPER MARKETS, INC 2 BLISTER PACK in 1 CARTON (56062-921-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK March 15, 2024
11822-8329-7 11822-8329 RITE AID 3 BLISTER PACK in 1 CARTON (11822-8329-7) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 1, 2020
11822-9999-3 11822-9999 RITE AID 3 BLISTER PACK in 1 CARTON (11822-9999-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK April 1, 2022
21130-646-20 21130-646 SAFEWAY 2 BLISTER PACK in 1 CARTON (21130-646-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 1, 2020
11673-111-30 11673-111 UP & UP 3 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK November 17, 2020
11673-115-30 11673-115 UP & UP 3 BLISTER PACK in 1 CARTON (11673-115-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK November 17, 2020
79903-008-30 79903-008 WAL-MART STORES, INC 3 BLISTER PACK in 1 CARTON (79903-008-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK January 1, 2021
79903-330-30 79903-330 WAL-MART STORES, INC 3 BLISTER PACK in 1 CARTON (79903-330-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK April 5, 2025
51316-821 51316-821 CVS PHARMACY, INC — March 15, 2024
69842-894 69842-894 CVS PHARMACY, INC — August 17, 2020
69842-895 69842-895 CVS PHARMACY, INC — August 17, 2020
51660-112 51660-112 Ohm Laboratories Inc. — August 19, 2020
51660-726 51660-726 Ohm Laboratories Inc. — March 15, 2024
56062-900 56062-900 PUBLIX SUPER MARKETS, INC — September 1, 2020
56062-921 56062-921 PUBLIX SUPER MARKETS, INC — March 15, 2024
11822-8329 11822-8329 RITE AID — September 1, 2020
11822-9999 11822-9999 RITE AID — April 1, 2022
21130-646 21130-646 SAFEWAY — September 1, 2020
11673-111 11673-111 UP & UP — November 17, 2020
11673-115 11673-115 UP & UP — November 17, 2020
79903-008 79903-008 WAL-MART STORES, INC — January 1, 2021
79903-330 79903-330 WAL-MART STORES, INC — April 5, 2025

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 · 9 sections on this page.