ADVIL COLD AND SINUS
- Product NDC
- 0573-0184
- 11-digit product format
- 005730184
- Labeler code
- 0573
- Product ID
- 0573-0184_3e883935-a6b2-f5fc-e063-6294a90a7789
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen, pseudoephedrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA021374
- Marketing category
- NDA
- Marketing start
- 2002-05-30
- 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
- ADVIL COLD AND SINUS
- 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 | 1299018 |
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 |
|---|
| 0573-0184-16 | ADVIL COLD AND SINUS | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 13 |
| 0573-0184-16 | ADVIL COLD AND SINUS | 16 in 1 CARTON | CAPSULE, LIQUID FILLED | 16 | | 13 |
| 0573-0184-32 | ADVIL COLD AND SINUS | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 13 |
| 0573-0184-32 | ADVIL COLD AND SINUS | 32 in 1 CARTON | CAPSULE, LIQUID FILLED | 32 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| pseudoephedrine hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| ibuprofen | ACTIVE MOIETY | WK2XYI10QM | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| coconut acid | INACTIVE INGREDIENT | 40U37V505D | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| potassium hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| sorbitan | INACTIVE INGREDIENT | 6O92ICV9RU | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0573-0184 | ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240622_0da9ed22-bfb4-d61b-110b-0c7760332a98.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 |
|---|
| 0573-0184-16 | 00573018416 | 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 blister pack | 2002-05-30 | 0000-00-00 | No | No | Current |
| 0573-0184-32 | 00573018432 | 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 32 blister pack | 2002-05-30 | 0000-00-00 | No | No | Current |