cold, flu and sore throat
- Product NDC
- 51013-197
- 11-digit product format
- 510130197
- Labeler code
- 51013
- Product ID
- 51013-197_4f724590-9b55-4d4b-b7e1-e2534af8e665
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2017-07-12
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51013-197-14 | cold, flu and sore throat | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | | 2 |
| 51013-197-14 | cold, flu and sore throat | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51013-197 | COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] | 2 | Legacy NDC, 2 package rows | 20200103_87e5e966-e680-4ae6-bb1d-3ed1603b76d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51013-197-14 | 51013019714 | 2 BLISTER PACK in 1 CARTON (51013-197-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2017-07-12 | 0000-00-00 | No | No | Current |