Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Cold And Flu Relief NDC 80513-304
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate · Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · Advanced Rx LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)80513-304Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0304Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-304-50 | 8051303045080513030450 | 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-304-50)Marketed from Mar 1, 2024 |
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, dextromethorphan hydrobromide, and doxylamine succinate
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/1Doxylamine succinate — 6.25 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- 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 80513-304_14ddc061-b1ab-5f66-e063-6394a90af806SPL ID 14ddc061-b1ab-5f66-e063-6394a90af806SPL set ID d1542362-19c5-4470-89e8-87d26e2ca8edRxCUI 1094549UNII 9D2RTI9KYH, V9BI9B5YI2, 362O9ITL9D
- 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
N480513030450followed by a unit qualifier and the quantityPackage 80513-0304-50. 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 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 80513-304
- What is NDC 80513-304?
- 80513-304 is the product NDC for Nighttime Cold And Flu Relief, Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Cold And Flu Relief (Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Doxylamine succinate, Acetaminophen.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. 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?
- 18 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 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) | 83324-158 | 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) | 83324-159 | 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) | 83324-163 | 83324-0163-12 |
| Nighttime Cold and Flu Reliefacetaminophen dextromethorphan hbr doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-164 | 83324-0164-08 |
| 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 hbr, doxylamine succinate | Doxylamine succinate 6.25 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | BETTER LIVING BRANDS LLC. | 21130-940 | 21130-0940-24 |
| Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-968 | 55319-0968-0855319-0968-1655319-0968-24 |
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 |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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