Sinus Congestion and Pain
- Product NDC
- 0536-1289
- 11-digit product format
- 005361289
- Labeler code
- 0536
- Product ID
- 0536-1289_2d0ea37f-038f-4803-a7d7-19b1c7c0d295
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-05-21
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 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
- Sinus Congestion and Pain
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 04JA59TNSJ |
| Rxcui | 1046378 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1289-35 | Sinus Congestion and PainMaximum Strength | 2 in 1 CARTON | TABLET | 2 | | 9 |
| 0536-1289-35 | Sinus Congestion and PainMaximum Strength | 12 in 1 BLISTER PACK | TABLET | 12 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1289 | SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [RUGBY LABORATORIES] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250215_fc42e97d-1224-4d29-a55d-1a1885e0bf8f.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 |
|---|
| 0536-1289-35 | 00536128935 | 2 BLISTER PACK in 1 CARTON (0536-1289-35) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2020-05-21 | 0000-00-00 | No | No | Current |