Cough and Cold
- Product NDC
- 58596-001
- Requested package NDC
- 58596-001-06
- 11-digit product format
- 585960001
- Labeler code
- 58596
- Product ID
- 58596-001_9c9504a4-c6cb-362b-e053-2a95a90a5715
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Selgel M
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-07-31
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 250 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| POLYETHYLENE GLYCOL 1000 | INACTIVE INGREDIENT | U076Q6Q621 | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE ) CAPSULE, LIQUID FILLED [SELGEL MÉXICO, S.A. DE C.V.] | 2 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58596-001-06 | 58596000106 | 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58596-001-06) | 2018-10-15 | 0000-00-00 | No | No | Current |