ibuprofen pm
- Product NDC
- 11822-0050
- 11-digit product format
- 118220050
- Labeler code
- 11822
- Product ID
- 11822-0050_4b815346-969e-4f5a-af95-09d3c984b36c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Citrate, Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2009-03-19
- Marketing end
- 2026-10-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ibuprofen pm
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 |
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 |
|---|
| 11822-0050-1 | ibuprofen pm | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 8 |
| 11822-0050-1 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 11822-0050-2 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 11822-0050-2 | ibuprofen pm | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 8 |
| 11822-0050-3 | ibuprofen pm | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 8 |
| 11822-0050-3 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 11822-0050-4 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 11822-0050-4 | ibuprofen pm | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 11822-0050-5 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 11822-0050-5 | ibuprofen pm | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE CITRATE | ACTIVE INGREDIENT | 4OD433S209 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [RITE AID CORPORATION] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11822-0050 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [RITE AID CORPORATION] | 7 | Current NDC, Legacy NDC, 10 package rows | 20230928_d9eefb84-cc2e-4deb-a1c0-a7c21929f5ac.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 |
|---|
| 11822-0050-1 | 11822005001 | 1 BOTTLE in 1 CARTON (11822-0050-1) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2009-06-24 | 2026-08-31 | No | No | Current |
| 11822-0050-2 | 11822005002 | 1 in 1 CARTON | | | | | | Historical |
| 11822-0050-3 | 11822005003 | 1 BOTTLE in 1 CARTON (11822-0050-3) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2009-03-19 | 2026-10-31 | No | No | Current |
| 11822-0050-4 | 11822005004 | 1 in 1 CARTON | | | | | | Historical |
| 11822-0050-5 | 11822005005 | 1 BOTTLE in 1 CARTON (11822-0050-5) / 120 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-08-23 | 2026-08-31 | No | No | Historical |