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NDC 36800-0661-16 TopCare 525 mg/30mL Details
TopCare 525 mg/30mL
TopCare is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is BISMUTH SUBSALICYLATE.
MedlinePlus Drug Summary
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.
Related Packages: 36800-0661-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 36800-0661 |
|---|---|
| Product ID | 36800-661_57cc6a4b-adbb-4606-8afd-e18fc8abb20e |
| Associated GPIs | |
| GCN Sequence Number | 002858 |
| GCN Sequence Number Description | bismuth subsalicylate ORAL SUSP 262MG/15ML ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 26970 |
| HICL Sequence Number | 001246 |
| HICL Sequence Number Description | BISMUTH SUBSALICYLATE |
| Brand/Generic | Generic |
| Proprietary Name | TopCare |
| Proprietary Name Suffix | Regular Strength |
| Non-Proprietary Name | Bismuth subsalicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 525 |
| Active Ingredient Units | mg/30mL |
| Substance Name | BISMUTH SUBSALICYLATE |
| Labeler Name | TOPCO ASSOCIATES LLC |
| Pharmaceutical Class | Bismuth [CS], Bismuth [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M008 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0661-16 (36800066116)
| NDC Package Code | 36800-661-16 |
|---|---|
| Billing NDC | 36800066116 |
| Package | 473 mL in 1 BOTTLE (36800-661-16) |
| Marketing Start Date | 2019-05-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |