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NDC 72189-0181-18 SORE THROAT LOGENZES SORE THROAT- 15; 3.6 mg/1; mg/1 Details
SORE THROAT LOGENZES SORE THROAT- 15; 3.6 mg/1; mg/1
SORE THROAT LOGENZES SORE THROAT- is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. The primary component is BENZOCAINE; MENTHOL.
Product Information
NDC | 72189-0181 |
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Product ID | 72189-181_cd382584-d4b3-a16c-e053-2995a90a6046 |
Associated GPIs | 88359902154795 |
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 | SORE THROAT LOGENZES SORE THROAT- |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzocaine and menthol |
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 | DIRECT RX |
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 72189-0181-18 (72189018118)
NDC Package Code | 72189-181-18 |
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Billing NDC | 72189018118 |
Package | 18 LOZENGE in 1 CARTON (72189-181-18) |
Marketing Start Date | 2021-02-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bc066943-fcb3-234b-e053-2995a90acdeb Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.
Do not use in a child under 5 years of age.
Stop use and ask a doctor or dentist if
sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
SORE THROAT LOGENZES SORE THROAT-
benzocaine and menthol lozenge |
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Labeler - DIRECT RX (079254320) |
Registrant - DIRECT RX (079254320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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DIRECT RX | 079254320 | relabel(72189-181) |