Over-the-counter drug · OTC MONOGRAPH DRUG
Mucus Relief Childrens NDC 76162-057
dextromethorphan hbr, guaifenesin, phenylephrine hcl · Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients · Solution · Oral · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-057-88 | 76162005788 | 1 BOTTLE, PLASTIC in 1 CARTON (76162-057-88) / 201 mL in 1 BOTTLE, PLASTICMarketed from Mar 7, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mucus Relief ChildrensSuffix: Childrens
- Generic name (nonproprietary)
- dextromethorphan hbr, guaifenesin, phenylephrine hcl
- Active ingredients
- Dextromethorphan hydrobromide — 5 mg/5mLGuaifenesin — 100 mg/5mLPhenylephrine hydrochloride — 2.5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- TOPCO ASSOCIATES LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-057_afe98f9d-a04c-47c3-928c-f5696adb14c5SPL ID afe98f9d-a04c-47c3-928c-f5696adb14c5SPL set ID 7b095ec5-9951-4491-9b68-7ac0a7f10053RxCUI 1043543UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476162005788followed by a unit qualifier and the quantityPackage 76162-0057-88. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants nasal congestion due to a cold the intensity of coughing stuffy nose the impulse to cough to help the child get to sleep
Excerpt only. Read the full label for complete information.
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| XL-3 Day Timeacetaminophen, dextromethorphan hbr, phenylephrine hcl | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | Rnv LLC | 84379-441 |
| Halls Sugar Free Watermelonmenthol | Menthol 2.5 mg/1 | LozengeOral | Mondelez Global LLC | 12546-351 |
| Xpect Cherry Cough Dropscherry cough drops | Menthol 7 mg/1 | LozengeOral | Cintas Corporation | 42961-232 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATacetaminophen and dextromethorphan hydrobromide | Acetaminophen 160 mg/5mL; Dextromethorphan hydrobromide 5 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-194 |
| Nighttime Cough DMdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | L.N.K. International, Inc. | 50844-043 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, CoatedOral | CVS Pharmacy, Inc. | 51316-221 |
| DayTime and Nighttime Cold/Flu Relief Softgels - Combo Packacetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate | — | Kit | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-605 |
| Sleep Aid NightTimediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-981 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Method Pharmaceuticals, LLC | 58657-500 |
| Dual Action Glacier Mint Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-603 |
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXacetaminophen, dextromethorphan hydrobromide tablet, coated | Dextromethorphan hydrobromide 10 mg/1; Acetaminophen 325 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6204 |
| Multi Symptom Severe Coldacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 500 mg/1 + 2 more ingredients | Powder, For solutionOral | RARITAN PHARMACEUTICALS INC | 68163-547 |
| Vicks DayQuil Cough DM plus Congestiondextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-922 |
| dimaphen dmbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL + 2 more ingredients | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8134 |
| Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Harris Teeter, LLC | 69256-343 |
| Cold and Flu Dayacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Walgreen Company | 0363-9912 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGeldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-052 |
| SofSkin Vaporizing Chest Rub and Cough Suppressantcamphor, menthol, eucalyptus oil | Camphor (Natural) 4.8 g/100g + 2 more ingredients | OintmentTopical | Viny Health and Beauty Inc | 76436-144 |
| Nighttime Cold and Flu Multi Symptom Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0177 |
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