Ibuprofen and Pseudoephedrine Hydrochloride
- Product NDC
- 56062-423
- 11-digit product format
- 560620423
- Labeler code
- 56062
- Product ID
- 56062-423_645177a7-1d43-439b-9e23-75d5a7822d98
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, SUGAR COATED
- Route
- ORAL
- Labeler
- Publix Super Markets Inc
- Application
- ANDA074567
- Marketing category
- ANDA
- Marketing start
- 2001-10-13
- Substance
- IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 200; 30 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen and Pseudoephedrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM, 6V9V2RYJ8N |
| Rxcui | 1299021 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 56062-423-21 | Ibuprofen and Pseudoephedrine Hydrochloride | 20 in 1 BLISTER PACK | TABLET, SUGAR COATED | 20 | | 3 |
| 56062-423-41 | Ibuprofen and Pseudoephedrine Hydrochloride | 40 in 1 BLISTER PACK | TABLET, SUGAR COATED | 40 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| TRISTEARIN | INACTIVE INGREDIENT | P6OCJ2551R | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 56062-423 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20181025_2b98a62b-bd92-4fb8-ad0f-521cb477b612.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 |
|---|
| 56062-423-21 | 56062042321 | 20 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-21) | 2001-10-13 | 0000-00-00 | No | No | Current |
| 56062-423-41 | 56062042341 | 40 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-41) | 2001-10-13 | 0000-00-00 | No | No | Current |