Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Cold and Flu Relief (Acetaminophen) NDC 69168-418
Acetaminophen 325 mg/1 + 2 more ingredients · Capsule · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0418Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-418-29 | 69168041829 | 8 CAPSULE in 1 BLISTER PACK (69168-418-29)Marketed from Nov 11, 2020 | |
| 69168-418-51 | 69168041851 | 20 CAPSULE in 1 BLISTER PACK (69168-418-51)Marketed from Nov 11, 2020 |
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 Relief
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 15 mg/1Doxylamine succinate — 6.25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- 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 69168-418_1cf8bb4f-4be1-4670-9329-b0eae96944bbSPL ID 1cf8bb4f-4be1-4670-9329-b0eae96944bbSPL set ID b97126d7-847d-483e-b3d1-e2b61ab1743fRxCUI 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
N469168041829followed by a unit qualifier and the quantityPackage 69168-0418-29. 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)
Use(s) temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing
Excerpt only. Read the full label for complete information.
About NDC 69168-418
- What is NDC 69168-418?
- 69168-418 is the product NDC for Nighttime Cold and Flu Relief (acetaminophen), Acetaminophen 325 mg/1 + 2 more ingredients capsule, listed with the FDA by Allegiant Health. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Cold and Flu Relief (Acetaminophen).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. 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 Relief?
- 19 other product NDCs are listed under this name. See all Nighttime Cold and Flu Relief 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 Relief 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 Flu Relief | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Grocery Outlet | 85828-418 | 85828-0418-93 |
| Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | SALADO SALES INC. | 57243-603 | 57243-0603-03 |
| Nighttime Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Bi-Mart | 37835-522 | 37835-0522-2437835-0522-96 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-164 | 83324-0164-08 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-148 | 83324-0148-24 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-159 | 83324-0159-08 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-158 | 83324-0158-12 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-163 | 83324-0163-12 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Aurohealth LLC | 58602-769 | 58602-0769-7858602-0769-79 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-304 | 80513-0304-50 |
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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