Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) NDC 71679-101
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride · Acetaminophen 325 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · Health Pharma USA LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71679-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71679-0101Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71679-101-00 | 71679010100 | 3000 CAPSULE, LIQUID FILLED in 1 DRUM (71679-101-00)Marketed from Sep 24, 2025 |
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)
- Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Health Pharma USA LLCNDC labeler code 71679
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71679-101_3f86a539-828a-a6d3-e063-6294a90ab8c2SPL ID 3f86a539-828a-a6d3-e063-6294a90ab8c2SPL set ID a03befb4-d86d-43e4-8097-eda5c8bb25beRxCUI 1086997UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
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
N471679010100followed by a unit qualifier and the quantityPackage 71679-0101-00. 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: nasal congestion cough due to minor throat and bronchial irritation headache minor aches and pains fever sore throat
Excerpt only. Read the full label for complete information.
About NDC 71679-101
- What is NDC 71679-101?
- 71679-101 is the product NDC for Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME), Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Health Pharma USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) (Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
- Who is the labeler?
- Health Pharma USA LLC, NDC labeler code 71679. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)?
- 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 |
|---|---|---|---|---|
| Equate Kids Daytime Dex Cough Gelsdextromethorphan | Dextromethorphan hydrobromide 10 mg/1 | Tablet, ChewableOral | Walmart | 79903-337 |
| Nuvicare DayTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-018 |
| MGC Cough Dropsmenthol | Menthol, Unspecified form 5.4 mg/1 | LozengeOral | Medical Group Care LLC | 83173-109 |
| Pain Reliever PMacetaminophen diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-166 |
| Cough Dropsmenthol | Menthol 7.5 mg/1 | PastilleOral | United Natural Foods, Inc. | 83455-203 |
| Better Livingphenylephrine hydrochloride | Phenylephrine hydrochloride 1 g/100mL | SprayNasal | BETTER LIVING BRANDS LLC | 21130-728 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytimeacetaminophen, guaifenesin and phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0527 |
| nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | Spray, MeteredNasal | Rite Aid Corporation | 11822-6319 |
| Childrens Sudafed Nasal Decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 15 mg/5mL | SolutionOral | Kenvue Brands LLC | 50580-536 |
| Dye Free Wal Dryl Allergy childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Walgreens | 0363-0293 |
| Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Dextrum Laboratories, Inc | 65852-003 |
| Severe Sinus Daytime, Non-Drowsyacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Walgreen Company | 0363-5027 |
| Leader Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | Cardinal Health 110,Inc | 70000-0676 |
| Akin Cough Formula DMdextromethorphan, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Southern Sales & Service, Inc. | 69822-202 |
| CVS Health Chest Congestion Relief PEguaifenesin/phenylephrine | Guaifenesin 400 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-997 |
| Sinus Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-119 |
| Cough Drops Dollar General Assorted Flavors 80ctmenthol | Menthol 2.8 mg/1 | LozengeOral | Dollar General | 75712-042 |
| Mucinex Instasoothe Coughdextromethorphan hydrobromide | Dextromethorphan hydrobromide 5 mg/1 | LozengeOral | Reckitt Benckiser LLC | 72854-267 |
| Rayo Breath Chamomilementhol, camphor | Menthol 1 g/g; Camphor (Synthetic) 1 g/g | CreamTopical | Quimicas Handal de Centroamerica SA de CV | 83033-1620 |
| MGC Healthcough drops cherry | Menthol 5.8 mg/1 | LozengeOral | Medical Group Care LLC | 83173-100 |
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