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NDC 54859-0503-01 Orasep 2; .1; .5 mg/100mL; mg/100mL; mg/100mL Details
Orasep 2; .1; .5 mg/100mL; mg/100mL; mg/100mL
Orasep is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL.
Product Information
NDC | 54859-0503 |
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Product ID | 54859-503_e68250f2-c90d-4555-8d98-55b5906df24b |
Associated GPIs | 88359903242020 |
GCN Sequence Number | 016328 |
GCN Sequence Number Description | benzocaine/tan ac/menth/cpyrd SOLUTION MUCOUS MEM |
HIC3 | H0A |
HIC3 Description | LOCAL ANESTHETICS |
GCN | 68050 |
HICL Sequence Number | 006219 |
HICL Sequence Number Description | BENZOCAINE/TANNIC ACID/MENTHOL/CETYLPYRIDINIUM CHLORIDE |
Brand/Generic | Brand |
Proprietary Name | Orasep |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Benzocaine, Menthol, Cetylpyridinium Chloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | TOPICAL |
Active Ingredient Strength | 2; .1; .5 |
Active Ingredient Units | mg/100mL; mg/100mL; mg/100mL |
Substance Name | BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL |
Labeler Name | Llorens Pharmaceutical International Division |
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 | 2024-12-31 |
Package
Package Images

NDC 54859-0503-01 (54859050301)
NDC Package Code | 54859-503-01 |
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Billing NDC | 54859050301 |
Package | 30 mL in 1 BOTTLE (54859-503-01) |
Marketing Start Date | 2010-04-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ed70911b-9da8-4e1d-97fa-66b18d28516a Details
SPL UNCLASSIFIED SECTION
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Warnings:
Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.
Sore throat warning: If sore throat is sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, consult a doctor promptly.
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens.
Do not exceed recommended dosage.
When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.
SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ORASEP
benzocaine, menthol, cetylpyridinium chloride liquid |
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Labeler - Llorens Pharmaceutical International Division (037342305) |