IBUPROFEN COLD AND SINUS
- Product NDC
- 46084-091
- 11-digit product format
- 460840091
- Labeler code
- 46084
- Product ID
- 46084-091_14d51b10-696d-4626-bb3b-143cde538b2f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A P J Laboratories Limited
- Application
- ANDA074567
- Marketing category
- ANDA
- Marketing start
- 2013-06-01
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 200 mg/1; mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 46084-091-60 | IBUPROFEN COLD AND SINUSA P J | 20 in 1 BLISTER PACK | TABLET, COATED | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| METHYLENE CHLORIDE | INACTIVE INGREDIENT | 588X2YUY0A | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46084-091 | IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED] | 1 | Legacy NDC, 1 package rows | 20130601_db492dad-ab1c-459d-842c-062e4b3f4c57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 46084-091-60 | 46084009160 | 20 in 1 BLISTER PACK | Historical |