Maximum Strength Cold, Flu and Sore Throat
- Product NDC
- 68210-4209
- 11-digit product format
- 682104209
- Labeler code
- 68210
- Product ID
- 68210-4209_ee9f075b-6b22-139c-e053-2995a90aa5be
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-19
- 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 |
|---|
| 68210-4209-1 | Maximum Strength Cold, Flu and Sore Throat | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 5 |
| 68210-4209-1 | Maximum Strength Cold, Flu and Sore Throat | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4209 | MAXIMUM STRENGTH COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 5 | Legacy NDC, 2 package rows | 20250101_845f984f-afea-4935-84cf-0450cc6d5691.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 |
|---|
| 68210-4209-1 | 68210420901 | 1 BLISTER PACK in 1 CARTON (68210-4209-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2022-08-19 | 0000-00-00 | No | No | Current |