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NDC 63868-0055-18 Cherry Sore Throat Lozenge 15; 3.6 mg/1; mg/1 Details
Cherry Sore Throat Lozenge 15; 3.6 mg/1; mg/1
Cherry Sore Throat Lozenge is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Quality Choice. The primary component is BENZOCAINE; MENTHOL.
Product Information
NDC | 63868-0055 |
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Product ID | 63868-055_eca759ee-4196-2762-e053-2a95a90aed5a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Cherry Sore Throat Lozenge |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Benzocaine |
Product Type | HUMAN OTC DRUG |
Dosage Form | LOZENGE |
Route | ORAL |
Active Ingredient Strength | 15; 3.6 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | BENZOCAINE; MENTHOL |
Labeler Name | Quality Choice |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 63868-0055-18 (63868005518)
NDC Package Code | 63868-055-18 |
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Billing NDC | 63868005518 |
Package | 18 LOZENGE in 1 BLISTER PACK (63868-055-18) |
Marketing Start Date | 2015-07-08 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 45364be4-615e-6576-e054-00144ff88e88 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Methemoglobinemia Warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Sore throat warning: If sore throat is, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
CHERRY SORE THROAT LOZENGE
benzocaine lozenge |
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Labeler - Quality Choice (011920774) |
Registrant - BestCo Inc (002149136) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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BestCo Inc | 002149136 | manufacture(63868-055) |