Maximum strength Tussnex FM DM Max
- Product NDC
- 53041-628
- 11-digit product format
- 530410628
- Labeler code
- 53041
- Product ID
- 53041-628_e39a2556-4a5b-4306-b2d1-b93b75d39b06
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-05-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 mg/20mL; mg/20mL
- Pharmacologic classes
- 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]
- 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 Tussnex FM DM Max
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1020138 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-628-58 | Maximum strength Tussnex FM DM Max | 177 mL in 1 BOTTLE | LIQUID | 177 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-628 | MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241222_0bae53e3-9661-4bc6-9fcc-da7fa131b034.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 |
|---|
| 53041-628-58 | 53041062858 | 177 mL in 1 BOTTLE (53041-628-58) | 177 ml | 2012-05-01 | 0000-00-00 | No | No | Current |