Over-the-counter drug · OTC MONOGRAPH FINAL
NightTime Cold and Flu NDC 76168-056
acetaminophen,dextromethorphan,doxylamine · Acetaminophen 325 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · Velocity Pharma
NDC codes
FDA NDC DirectoryProduct NDC (as listed)76168-056Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76168-0056Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76168-056-02 | 7616800560276168005602 | 12 CARTON in 1 BLISTER PACK (76168-056-02) / 1 CAPSULE, LIQUID FILLED in 1 CARTONMarketed from Aug 1, 2017 |
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)
- NightTime Cold and Flu
- Generic name (nonproprietary)
- acetaminophen,dextromethorphan,doxylamine
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 15 mg/1Doxylamine succinate — 6.25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Velocity PharmaNDC labeler code 76168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76168-056_58ee90a2-07a9-2253-e053-2a91aa0ad9cfSPL ID 58ee90a2-07a9-2253-e053-2a91aa0ad9cfSPL set ID 516fc924-61f0-40ee-9688-3c6da817b462RxCUI 1094549UNII 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
N476168005602followed by a unit qualifier and the quantityPackage 76168-0056-02. 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 pain reliever, cough suppressant and Antihistamine
Excerpt only. Read the full label for complete information.
About NDC 76168-056
- What is NDC 76168-056?
- 76168-056 is the product NDC for NightTime Cold and Flu, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Velocity Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- NightTime Cold and Flu (Acetaminophen,Dextromethorphan,Doxylamine).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- Velocity Pharma, NDC labeler code 76168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for NightTime Cold and Flu?
- 26 other product NDCs are listed under this name. See all NightTime Cold and Flu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other NightTime Cold and Flu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nighttime Cold And Fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-322 | 72288-0322-67 |
| Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-117 | 72288-0117-62 |
| nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-921 | 51316-0921-40 |
| Nighttime Cold And Fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Amazon.com Services LLC | 72288-990 | 72288-0990-0072288-0990-01 |
| Nighttime Cold And Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Amazon.com Services LLC | 72288-670 | 72288-0670-0072288-0670-01 |
| Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Doxylamine succinate 12.5 mg/30mL + 2 more ingredients | LiquidOral | BETTER LIVING BRANDS LLC. | 21130-951 | 21130-0951-06 |
| Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-750 | 85828-0750-01 |
| Nighttime Cold And Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-884 | 51316-0884-40 |
| Nighttime Cold and Fluacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-102 | 71679-0102-00 |
| Nighttime Cold and Fluacetaminophen, dextromethrophan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | LiquidOral | Kroger | 41226-750 | 41226-0750-01 |
Other NDCs under part341
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 |
|---|---|---|---|---|
| Pseudo Time PEphenylephrine hchloride | Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC. | 49483-234 |
| Allergy Timechlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Time Cap Labs Inc | 49483-242 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-329 |
| CVS Health Sinus Reliefoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-787 |
| Severe Cold Head Congestionacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-175 |
| CVS Health Childrens Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | CVS Pharmacy,Inc. | 59779-793 |
| CVS Health Four Actions Nasal Decongestantphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-838 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Discount Drug Mart Value Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Drug Mart | 53943-256 |
| Pressure Pain Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-747 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma LLC | 76168-121 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Pi Yuan Chinnaphazoline hydrochloride | Naphazoline hydrochloride 1 mg/1 | Solution/ dropsNasal | International Nature Nutraceuticals | 51367-035 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strengthdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | WALGREEN CO. | 0363-0758 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
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