Sinus and Headache
- Product NDC
- 46122-658
- Requested package NDC
- 46122-658-62
- 11-digit product format
- 461220658
- Labeler code
- 46122
- Product ID
- 46122-658_e557d934-5d41-81de-e053-2a95a90a1c91
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AMERISOURCE BERGEN
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-08-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-658 | SINUS AND HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERISOURCE BERGEN] | 5 | Legacy NDC | 20241013_5347b46e-ddaa-42c0-ba25-75a4a542ae0f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46122-658-62 | 46122065862 | 2 BLISTER PACK in 1 PACKAGE (46122-658-62) > 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2020-08-01 | 0000-00-00 | No | No | Current |