Non-Drowsy Daytime Severe Cold Multi-Symptom
- Product NDC
- 68210-4166
- Requested package NDC
- 68210-4166-1
- 11-digit product format
- 682104166
- Labeler code
- 68210
- Product ID
- 68210-4166_ee8ee0ab-fc76-dc57-e053-2a95a90adf2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-06-29
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4166-1 | Non-Drowsy Daytime Severe Cold Multi-Symptom | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 68210-4166-1 | Non-Drowsy Daytime Severe Cold Multi-Symptom | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4166 | NON-DROWSY DAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 6 | Legacy NDC, 2 package rows | 20241215_529bc1ae-a1b2-4984-8757-33ba65071441.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 |
|---|
| 68210-4166-1 | 68210416601 | 1 BOTTLE in 1 CARTON (68210-4166-1) > 12 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-06-29 | 0000-00-00 | No | No | Current |