Over-the-counter drug · OTC MONOGRAPH DRUG
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF NDC 53943-501
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate · Acetaminophen 650 mg/30mL + 2 more ingredients · Liquid · Oral · Discount Drug Mart
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-501-28 | 53943050128 | 354 mL in 1 BOTTLE (53943-501-28)Marketed from Oct 21, 2014 |
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)
- Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEFSuffix: MULTI-SYMPTOM COLD/FLU RELIEF
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Active ingredients
- Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Discount Drug Mart
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53943-501_46538946-6c44-dce2-e063-6394a90ae990SPL ID 46538946-6c44-dce2-e063-6394a90ae990SPL set ID e243033b-6603-4c3e-a330-e7c7de51f69dRxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N453943050128followed by a unit qualifier and the quantityPackage 53943-0501-28. 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 cold/flu symptoms sore throat headache minor aches and pain fever runny nose and sneezing cough due to minor throat and bronchial irritation
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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