Safetussin
- Product NDC
- 55505-189
- Requested package NDC
- 55505-189-36
- 11-digit product format
- 555050189
- Labeler code
- 55505
- Product ID
- 55505-189_8d0b133f-c65b-4bd8-a09e-2616830cdafc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Kramer Laboratories
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-07-01
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10 mg/5mL; mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 55505-189 | 55505-189-36 | D | Discontinued by firm | 2026-10-12 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55505-189-36 | 55505018936 | 237 mL in 1 BOTTLE, PLASTIC (55505-189-36) | 237 ml | 2015-07-01 | 0000-00-00 | No | No | Current |