Imodium
- Product NDC
- 50580-134
- 11-digit product format
- 505800134
- Labeler code
- 50580
- Product ID
- 50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA019487
- Marketing category
- NDA
- Marketing start
- 2004-07-01
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/7.5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imodium
- Brand name suffix
- A-D
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 1 mg/7.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 1250685, 1250693 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-134-04 | ImodiumA-D | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 10 |
| 50580-134-08 | ImodiumA-D | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 10 |
| 50580-134-44 | ImodiumA-D | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Loperamide Hydrochloride | ACTIVE INGREDIENT | 77TI35393C | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| Loperamide | ACTIVE MOIETY | 6X9OC3H4II | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| carboxymethylcellulose sodium, unspecified form | INACTIVE INGREDIENT | K679OBS311 | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-134 | IMODIUM A-D (LOPERAMIDE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20241103_76a976d5-8bee-4158-a94d-7fbfc5544fd4.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 |
|---|
| 50580-134-04 | 50580013404 | 120 mL in 1 BOTTLE (50580-134-04) | 120 ml | 2004-07-01 | 0000-00-00 | No | No | Current |
| 50580-134-08 | 50580013408 | 240 mL in 1 BOTTLE (50580-134-08) | 240 ml | 2004-07-01 | 0000-00-00 | No | No | Current |
| 50580-134-44 | 50580013444 | 120 mL in 1 BOTTLE (50580-134-44) | 120 ml | 2004-07-01 | 0000-00-00 | No | No | Current |