Tussnex FM Cold and Sinus
- Product NDC
- 53041-616
- 11-digit product format
- 530410616
- Labeler code
- 53041
- Product ID
- 53041-616_3e372558-1578-4c25-962a-43af6b54de75
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acteaminophen, Guaifenesin, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-12-01
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 400; 10 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Tussnex FM Cold and Sinus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1116568 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-616-58 | Tussnex FM Cold and Sinus | 177 mL in 1 BOTTLE | LIQUID | 177 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-616 | TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241222_04c6bb6a-d2f8-4322-afba-e240e8090176.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 |
|---|
| 53041-616-58 | 53041061658 | 177 mL in 1 BOTTLE (53041-616-58) | 177 ml | 2012-12-01 | 0000-00-00 | No | No | Current |