Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Cough Relief NDC 83324-153
dextromethorphan hbr doxylamine succinate · Dextromethorphan hydrobromide 30 mg/30mL; Doxylamine succinate 12.5 mg/30mL · Liquid · Oral · QUALITY CHOICE (Chain Drug Marketing Association)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83324-153-08 | 8332401530883324015308 | 237 mL in 1 BOTTLE, PLASTIC (83324-153-08)Marketed from Jul 31, 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 Cough Relief
- Generic name (nonproprietary)
- dextromethorphan hbr doxylamine succinate
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)NDC labeler code 83324
- 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 83324-153_9f0252a4-c7c2-46ed-897d-586af670c1a8SPL ID 9f0252a4-c7c2-46ed-897d-586af670c1a8SPL set ID e1fa0f51-6a68-4f6f-8988-0949d1942c2fRxCUI 1234386UNII 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
N483324015308followed by a unit qualifier and the quantityPackage 83324-0153-08. 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 cold symptoms cough due to minor throat and bronchial irritation runny nose and sneezing
Excerpt only. Read the full label for complete information.
About NDC 83324-153
- What is NDC 83324-153?
- 83324-153 is the product NDC for Nighttime Cough Relief, Dextromethorphan hydrobromide 30 mg/30mL; Doxylamine succinate 12.5 mg/30mL liquid, listed with the FDA by QUALITY CHOICE (Chain Drug Marketing Association). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Cough Relief (Dextromethorphan HBr Doxylamine Succinate).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- QUALITY CHOICE (Chain Drug Marketing Association), NDC labeler code 83324. 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 Cough Relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | WALGREENS | 0363-0100 |
| CVS Health No Dripnasal mist | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CVS PHARMACY,INC. | 69842-815 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 69423-986 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 |
| basic care tussin dm maxdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Amazon.com Services LLC | 72288-293 |
| Menthol Cough Drops Honey Vanilla Flavormenthol | Menthol 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-013 |
| equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride | — | Kit | Sixarp, LLC | 59368-459 |
| Nasal Decongestant Maximum Strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-112 |
| Medicated Chest Rubcamphor, menthol, eucalyptus oil | Camphor (Synthetic) 4.8 g/100g + 2 more ingredients | CreamTopical | Jell Pharmaceuticals Pvt Ltd. | 30400-701 |
| equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-459 |
| NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-044 |
| Childrens Dye Free Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | P & L Development, LLC | 49580-0293 |
| Discount Drug Mart Original Nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-715 |
| Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Family Dollar Services Inc | 55319-705 |
| DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Dolgencorp Inc | 55910-928 |
| Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-8751 |
| Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride | — | KitNasal | Bayer HealthCare LLC. | 11523-0147 |
| Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | Selder, S.A. de C.V. | 63654-605 |
| Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05% | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Lil' Drug Store Products, Inc. | 66715-5526 |
| Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-982 |
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