Over-the-counter drug · OTC MONOGRAPH DRUG
Sinus And Headache NDC 53943-323
acetaminophen and phenylephrine hydrochloride · Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 · Tablet, Coated · Oral · DISCOUNT DRUG MART
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53943-323Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0323Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-323-05 | 5394303230553943032305 | 2 BLISTER PACK in 1 CARTON (53943-323-05) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Sep 1, 2020 |
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)
- Sinus And Headache
- Generic name (nonproprietary)
- acetaminophen and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- DISCOUNT DRUG MARTNDC labeler code 53943
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 53943-323_24adcdf2-1434-b681-e063-6394a90a9b02SPL ID 24adcdf2-1434-b681-e063-6394a90a9b02SPL set ID a7e99dad-5916-6a90-e053-2a95a90a8803RxCUI 1046378UNII 362O9ITL9D, 04JA59TNSJ
- Pharmacologic class
- 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
N453943032305followed by a unit qualifier and the quantityPackage 53943-0323-05. 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 these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53943-323
- What is NDC 53943-323?
- 53943-323 is the product NDC for Sinus And Headache, Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 tablet, coated, listed with the FDA by DISCOUNT DRUG MART. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sinus And Headache (ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Phenylephrine hydrochloride.
- Who is the labeler?
- DISCOUNT DRUG MART, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sinus And Headache?
- 8 other product NDCs are listed under this name. See all Sinus And Headache NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sinus And Headache products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sinus and Headacheacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-223 | 42507-0223-05 |
| Sinus And Headacheacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-4669 | 11822-4669-08 |
| Sinus and Headacheacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Family Dollar Services Inc | 55319-496 | 55319-0496-08 |
| Sinus and Headacheacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-923 | 57344-0923-05 |
| Sinus And Headacheacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-123 | 72476-0123-05 |
| Sinus and Headacheacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | GOODSENSE | 50804-123 | 50804-0123-05 |
| Sinus and Headacheacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-4066 | 00363-4066-08 |
| Sinus and Headacheacetaminophen and phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0568 | 70000-0568-01 |
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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