Over-the-counter drug · OTC MONOGRAPH DRUG
Daytime Cold and Flu NDC 53345-056
acetaminophen and dextromethorphan hydrobromide · Dextromethorphan hydrobromide 10 mg/1; Acetaminophen 325 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53345-056Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53345-0056Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53345-056-01 | 5334500560153345005601 | 1 BAG in 1 CARTON (53345-056-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Dec 28, 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)
- Daytime Cold and Flu
- Generic name (nonproprietary)
- acetaminophen and dextromethorphan hydrobromide
- Active ingredients
- Dextromethorphan hydrobromide — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdNDC labeler code 53345
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53345-056_46995a36-4233-ddce-e063-6294a90a1b8eSPL ID 46995a36-4233-ddce-e063-6294a90a1b8eSPL set ID 46996bbf-948c-0aba-e063-6394a90a09e3RxCUI 1867684UNII 9D2RTI9KYH, 362O9ITL9D
- Pharmacologic class
- 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
N453345005601followed by a unit qualifier and the quantityPackage 53345-0056-01. 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/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
Excerpt only. Read the full label for complete information.
About NDC 53345-056
- What is NDC 53345-056?
- 53345-056 is the product NDC for Daytime Cold and Flu, Dextromethorphan hydrobromide 10 mg/1; Acetaminophen 325 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daytime Cold and Flu (Acetaminophen and Dextromethorphan hydrobromide).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Acetaminophen.
- Who is the labeler?
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd, NDC labeler code 53345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daytime Cold and Flu?
- 37 other product NDCs are listed under this name. See all Daytime 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 Daytime 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) |
|---|---|---|---|---|---|
| Daytime Cold And Fluacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-654 | 72288-0654-67 |
| daytime cold and fluacetaminophen, dextromethorphan hydrobromide | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-710 | 72288-0710-62 |
| Daytime Cold And Fluacetaminophen, dextromethorphan hydrobromide | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-676 | 51316-0676-62 |
| Daytime Cold And Fluacetaminophen, dextromethorphan hydrobromide | Acetaminophen 325 mg/15mL; Dextromethorphan hydrobromide 10 mg/15mL | SolutionOral | Meijer, Inc. | 79481-5303 | 79481-5303-04 |
| Daytime Cold and Fluacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Amazon.com Services LLC | 72288-866 | 72288-0866-40 |
| Daytime Cold and Fluacetaminophen, dextromethorphan hydrobromide, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | BETTER LIVING BRANDS, LLC | 21130-947 | 21130-0947-06 |
| Daytime Cold and Fluacetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Grocery Outlet | 85828-417 | 85828-0417-93 |
| Daytime Cold and Fluacetaminophen, dextromethorphan hydrobromide, phenylephrine hcl | Phenylephrine hydrochloride 5 mg/15mL + 2 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-772 | 85828-0772-01 |
| Daytime Cold and Fluacetaminophen, dextromethorphan hbr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 51316-897 | 51316-0897-16 |
| daytime cold and fluacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-350 | 51316-0350-3451316-0350-40 |
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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