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NDC 70000-0553-01 Leader Honey Lemon Benzocaine Throat Lozenge 15; 2.6 mg/1; mg/1 Details
Leader Honey Lemon Benzocaine Throat Lozenge 15; 2.6 mg/1; mg/1
Leader Honey Lemon Benzocaine Throat Lozenge is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is BENZOCAINE; MENTHOL.
Product Information
| NDC | 70000-0553 |
|---|---|
| Product ID | 70000-0553_d551ea4c-26b2-7253-e053-2a95a90aecd9 |
| Associated GPIs | 88359902154793 |
| GCN Sequence Number | 067736 |
| GCN Sequence Number Description | benzocaine/menthol LOZENGE 15MG-2.6MG MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 30355 |
| HICL Sequence Number | 001675 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | Leader Honey Lemon Benzocaine 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; 2.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BENZOCAINE; MENTHOL |
| Labeler Name | Cardinal Health |
| 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 70000-0553-01 (70000055301)
| NDC Package Code | 70000-0553-1 |
|---|---|
| Billing NDC | 70000055301 |
| Package | 18 LOZENGE in 1 BLISTER PACK (70000-0553-1) |
| Marketing Start Date | 2020-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.08556 |
| Pricing Unit | EA |
| Effective Date | 2022-04-20 |
| NDC Description | SORE THROAT 15-2.6 MG LOZENGE |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL a7969a81-5280-0633-e053-2995a90ac11d Details
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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 severe, 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.
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INGREDIENTS AND APPEARANCE
| LEADER HONEY LEMON BENZOCAINE THROAT LOZENGE
benzocaine lozenge |
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| Labeler - Cardinal Health (063997360) |
| Registrant - Bestco LLC (002149136) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bestco LLC | 002149136 | manufacture(70000-0553) | |