CareOne Diarrhea and Gas Control
- Product NDC
- 41520-772
- 11-digit product format
- 415200772
- Labeler code
- 41520
- Product ID
- 41520-772_81170c0a-6219-4612-af10-a46d1858e3e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide hydrochloride, simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA209837
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Substance
- DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
- Active strength
- 125; 2 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CareOne Diarrhea and Gas Control
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 125 mg/1 |
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 77TI35393C |
| Rxcui | 978001 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41520-772-53 | CareOne Diarrhea and Gas Control | 12 in 1 CARTON | TABLET | 12 | | 5 |
| 41520-772-53 | CareOne Diarrhea and Gas Control | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-772 | CAREONE DIARRHEA AND GAS CONTROL (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [AMERICAN SALES COMPANY] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240724_dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41520-772-53 | 41520077253 | 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2019-01-31 | 0000-00-00 | No | No | Current |