Cold and Flu
- Product NDC
- 63941-163
- Requested package NDC
- 63941-163-05
- 11-digit product format
- 639410163
- Labeler code
- 63941
- Product ID
- 63941-163_d11a253c-a32f-1ccd-e053-2a95a90a5333
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- VALU MERCHANDISERS COMPANY
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2012-03-09
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 63941-163 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [VALU MERCHANDISERS COMPANY] | 3 | Legacy NDC | 20230913_afbe85f6-ad60-4747-8a7b-686fe38626c7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63941-163-05 | 63941016305 | 2 BLISTER PACK in 1 CARTON (63941-163-05) > 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2012-03-09 | 0000-00-00 | No | No | Current |