MAXIMUM STRENGTH COLD AND FLU
- Product NDC
- 55319-628
- 11-digit product format
- 553190628
- Labeler code
- 55319
- Product ID
- 55319-628_2e2c825a-b5bd-9b82-e063-6394a90aa88f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- FAMILY DOLLAR SERVICES
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-08-24
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MAXIMUM STRENGTH COLD AND FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1656815 |
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 |
|---|
| 55319-628-16 | MAXIMUM STRENGTH COLD AND FLU | 16 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 16 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-628 | MAXIMUM STRENGTH COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR SERVICES] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250217_a7343bea-53cc-4621-e053-2a95a90a2a5f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55319-628-16 | 55319062816 | 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16) | 2020-08-24 | 0000-00-00 | No | No | Current |