careone ibuprofen pm
- Product NDC
- 41520-413
- 11-digit product format
- 415200413
- Labeler code
- 41520
- Product ID
- 41520-413_e8dd6f2e-71e7-46be-adc3-cebdf6845ad1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine citrate, Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2011-12-08
- Marketing end
- 0000-00-00
- Substance
- DIPHENHYDRAMINE CITRATE; IBUPROFEN
- Active strength
- 38 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE CITRATE | ACTIVE INGREDIENT | 4OD433S209 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-413 | CAREONE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY] | 4 | Legacy NDC | 20190207_8bfbb5b5-67f5-4a87-a926-10f140353ab5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41520-413-27 | 41520041327 | 1 BOTTLE in 1 CARTON (41520-413-27) > 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-09-05 | 0000-00-00 | No | No | Current |