Sinus and Headache
- Product NDC
- 68016-174
- Requested package NDC
- 68016-174-24
- 11-digit product format
- 680160174
- Labeler code
- 68016
- Product ID
- 68016-174_efb7586a-0c0a-99c3-e053-2a95a90af420
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG CONSORTIUM
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-09-01
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68016-174 | 68016-174-24 | D | Discontinued by firm | 2026-10-16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-174-24 | 68016017424 | 2 BLISTER PACK in 1 CARTON (68016-174-24) > 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2020-09-01 | 0000-00-00 | No | No | Current |