Motrin
- Product NDC
- 50580-563
- 11-digit product format
- 505800563
- Labeler code
- 50580
- Product ID
- 50580-563_39a34ab2-9fae-444e-e063-6294a90a9152
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen and Diphenhydramine Citrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2010-01-11
- Substance
- DIPHENHYDRAMINE CITRATE; IBUPROFEN
- Active strength
- 38; 200 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Motrin
- Brand name suffix
- PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE CITRATE | 38 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4OD433S209, WK2XYI10QM |
| Rxcui | 895664, 895666 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-563-20 | MotrinPM | 1 in 1 CARTON | TABLET, COATED | 1 | | 12 |
| 50580-563-20 | MotrinPM | 20 in 1 BOTTLE, PLASTIC | TABLET, COATED | 20 | | 12 |
| 50580-563-40 | MotrinPM | 40 in 1 BOTTLE, PLASTIC | TABLET, COATED | 40 | | 12 |
| 50580-563-40 | MotrinPM | 1 in 1 CARTON | TABLET, COATED | 1 | | 12 |
| 50580-563-80 | MotrinPM | 80 in 1 BOTTLE, PLASTIC | TABLET, COATED | 80 | | 12 |
| 50580-563-80 | MotrinPM | 1 in 1 CARTON | TABLET, COATED | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Diphenhydramine Citrate | ACTIVE INGREDIENT | 4OD433S209 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| glyceryl dibehenate | INACTIVE INGREDIENT | R8WTH25YS2 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| hydroxypropyl cellulose (Type E) | INACTIVE INGREDIENT | 66O7AQV0RT | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-563 | MOTRIN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [KENVUE BRANDS LLC] | 11 | Current NDC, Legacy NDC, 6 package rows | 20241109_55403f19-58ae-450b-8a7b-0bc544088f20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-563-20 | 50580056320 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC | 2010-01-11 | 0000-00-00 | No | No | Current |
| 50580-563-40 | 50580056340 | 40 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 50580-563-80 | 50580056380 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC | 2010-01-11 | 0000-00-00 | No | No | Current |