Sinus Severe
- Product NDC
- 68016-504
- Requested package NDC
- 68016-504-24
- 11-digit product format
- 680160504
- Labeler code
- 68016
- Product ID
- 68016-504_af0d544d-c462-2dc2-e053-2a95a90a75a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG CONSORTIUM
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2009-11-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-504-24 | Sinus Severe | 2 in 1 CARTON | TABLET, COATED | 2 | | 3 |
| 68016-504-24 | Sinus Severe | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-504 | SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG CONSORTIUM] | 3 | Legacy NDC, 2 package rows | 20241013_01a1183d-deec-40ca-94da-a6e40b7af2c7.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 |
|---|
| 68016-504-24 | 68016050424 | 2 BLISTER PACK in 1 CARTON (68016-504-24) > 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2009-11-01 | 0000-00-00 | No | No | Current |