Over-the-counter drug · OTC MONOGRAPH DRUG
Daytime Cold and Flu NDC 0363-0853
acetaminophine dextromethorphan hbr phenylphrine hcl · Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · WALGREENS
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-0853Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0853Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0853-07 | 0036308530700363085307 | 1 BLISTER PACK in 1 CARTON (0363-0853-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 3, 2023 | |
| 0363-0853-16 | 0036308531600363085316 | 2 BLISTER PACK in 1 CARTON (0363-0853-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 15, 2021 | |
| 0363-0853-24 | 0036308532400363085324 | 2 BLISTER PACK in 1 CARTON (0363-0853-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 15, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- acetaminophine dextromethorphan hbr phenylphrine hcl
- Active ingredients
- Phenylephrine hydrochloride — 5 mg/1Dextromethorphan hydrobromide — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- WALGREENSNDC labeler code 0363
- 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 0363-0853_13b1a0d2-6b18-a20f-e063-6294a90a35b2SPL ID 13b1a0d2-6b18-a20f-e063-6294a90a35b2SPL set ID d315bc95-1b46-75df-e053-2a95a90a6c66RxCUI 1086997UNII 04JA59TNSJ, 9D2RTI9KYH, 362O9ITL9D
- 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
N400363085307followed by a unit qualifier and the quantityPackage 00363-0853-07. 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: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Excerpt only. Read the full label for complete information.
About NDC 0363-0853
- What is NDC 0363-0853?
- 0363-0853 is the product NDC for Daytime Cold and Flu, Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by WALGREENS. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daytime Cold and Flu (Acetaminophine Dextromethorphan HBr Phenylphrine HCl).
- What is the active ingredient?
- Phenylephrine hydrochloride, Dextromethorphan hydrobromide, Acetaminophen.
- Who is the labeler?
- WALGREENS, NDC labeler code 0363. 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 |
|---|---|---|---|---|
| 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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