Sound Body Cold and Flu Relief
- Product NDC
- 50594-016
- Requested package NDC
- 50594-016-40
- 11-digit product format
- 505940016
- Labeler code
- 50594
- Product ID
- 50594-016_3e08c72c-3ee9-4382-8e58-34fef51a9f2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Big Lots Stores, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2016-05-03
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 50594-016 | 50594-016-40 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50594-016 | 50594-016-40 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 |
|---|---|---|---|---|---|---|---|---|
| 50594-016-40 | 50594001640 | 355 mL in 1 BOTTLE (50594-016-40) | 355 ml | 2016-05-03 | 0000-00-00 | No | No | Current |