Over-the-counter drug · OTC MONOGRAPH DRUG
Cold and Flu Nighttime NDC 63868-234
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate · Acetaminophen 650 mg/30mL + 2 more ingredients · Liquid · Oral · QUALITY CHOICE (Chain Drug Marketing Association)
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63868-234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0234Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-234-08 | 63868023408 | 237 mL in 1 BOTTLE, PLASTIC (63868-234-08)Marketed from Aug 31, 2016 | |
| 63868-234-12 | 63868023412 | 355 mL in 1 BOTTLE, PLASTIC (63868-234-12)Marketed from Aug 31, 2016 |
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)
- Cold and Flu NighttimeSuffix: Nighttime
- 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
- QUALITY CHOICE (Chain Drug Marketing Association)NDC labeler code 63868
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Marketing end
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63868-234_970d9c21-b0c9-455e-993c-d333dd08245aSPL ID 970d9c21-b0c9-455e-993c-d333dd08245aSPL set ID e70d0784-53bc-4910-aade-3c9ad6e36441RxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2UPC 0635515900097
- 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
N463868023408followed by a unit qualifier and the quantityPackage 63868-0234-08. 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 these common cold/flu symptoms: minor aches and pains headache fever sore throat runny nose and sneezing cough due to minor throat and bronchial irritation
Excerpt only. Read the full label for complete information.
About NDC 63868-234
- What is NDC 63868-234?
- 63868-234 is the product NDC for Cold and Flu Nighttime, Acetaminophen 650 mg/30mL + 2 more ingredients liquid, listed with the FDA by QUALITY CHOICE (Chain Drug Marketing Association). It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cold and Flu Nighttime (Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- QUALITY CHOICE (Chain Drug Marketing Association), NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cold and Flu Nighttime?
- 11 other product NDCs are listed under this name. See all Cold and Flu Nighttime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cold and Flu Nighttime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Cardinal Health 110, LLC. DBA Leader | 70000-0673 | 70000-0673-01 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, triprolidine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | SolutionOral | Walgreen Company | 0363-8063 | 00363-8063-45 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, triprolidine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-963 | 51316-0963-45 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 | 71141-0180-32 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, triprolidine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | SolutionOral | WALMART INC. | 79903-119 | 79903-0119-45 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Walgreens | 0363-3430 | 00363-3430-12 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Bi-Mart | 37835-524 | 37835-0524-02 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-443 | 55910-0443-12 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Best Choice (Valu Merchandisers Company) | 63941-343 | 63941-0343-0863941-0343-12 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Best Choice (Valu Merchandisers Company) | 63941-344 | 63941-0344-0863941-0344-12 |
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 |
|---|---|---|---|---|
| equate allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-297 |
| Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Doxylamine succinate 12.5 mg/30mL + 3 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-775 |
| Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Belmora LLC | 27854-299 |
| Allergy Reliefdiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9285 |
| Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl | — | Kit | Kroger Company | 30142-616 |
| nasal decongestantoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | A-S Medication Solutions | 50090-5281 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola Ag | 54305-342 |
| Geri-Tussin DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-661 |
| Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL | LiquidOral | FAMILY DOLLAR SERVICES INC | 55319-754 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-925 |
| Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | Gil Pharmaceutical Corp | 58552-332 |
| Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate | — | Kit | Haleon US Holdings LLC | 0031-2099 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0505 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 63824-956 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | NuCare Pharmaceuticals, Inc. | 68071-3858 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1799 |
| nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-2029 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | BIONPHARMA INC. | 69452-445 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
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