| NDC Code | 0121-1095-03 |
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| Package Description | 25 SYRINGE, PLASTIC in 1 CARTON (0121-1095-03) / .6 mL in 1 SYRINGE, PLASTIC (0121-1095-01) |
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| Product NDC | 0121-1095 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Childrens Simethicone Drops |
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| Non-Proprietary Name | Childrens Simethicone Drops |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20260608 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M002 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | DIMETHICONE |
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| Strength | 40 |
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| Strength Unit | mg/.6mL |
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| Pharmacy Classes | Skin Barrier Activity [PE] |
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