Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride NDC 35916-0167
Acetaminophen 325 mg/1 + 3 more ingredients · Capsule, Liquid filled · Oral · SOFTGEL HEALTHCARE PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35916-0167-1 | 35916016701 | 2 BLISTER PACK in 1 CARTON (35916-0167-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 22, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1Doxylamine succinate — 6.25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 35916-0167_47c7e929-e897-88c0-e063-6394a90a5821SPL ID 47c7e929-e897-88c0-e063-6394a90a5821SPL set ID 1fcbafaa-c871-db6d-e063-6394a90aab5eRxCUI 1297288UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ, V9BI9B5YI2UPC 0335916016716
- Pharmacologic class
- Antihistamine; 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
N435916016701followed by a unit qualifier and the quantityPackage 35916-0167-01. 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 temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage
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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