Over-the-counter drug · OTC MONOGRAPH DRUG
Severe Sinus Congestion and Pain NDC 83059-0107
acetaminophen, guaifenesin, phenylephrine · Acetaminophen 325 mg/1 + 2 more ingredients · Tablet, Coated · Oral · Shield Pharmaceuticals Corp
NDC codes
FDA NDC DirectoryProduct NDC (as listed)83059-0107Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83059-0107Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83059-0107-1 | 8305901070183059010701 | 1 BLISTER PACK in 1 CARTON (83059-0107-1) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Nov 8, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Severe Sinus Congestion and Pain
- Generic name (nonproprietary)
- acetaminophen, guaifenesin, phenylephrine
- Active ingredients
- Acetaminophen — 325 mg/1Guaifenesin — 200 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Shield Pharmaceuticals CorpNDC labeler code 83059
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 83059-0107_431b23cf-64ff-1377-e063-6394a90a3ca3SPL ID 431b23cf-64ff-1377-e063-6394a90a3ca3SPL set ID 103de130-ef12-4c58-bbcf-234b3f3b2cbfRxCUI 1243679UNII 362O9ITL9D, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; 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
N483059010701followed by a unit qualifier and the quantityPackage 83059-0107-01. 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 these symptoms associated with hay fever or other respiratory allergies, and the common cold: • sinus congestion and pressure • headache • nasal congestion • minor aches and pains • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 83059-0107
- What is NDC 83059-0107?
- 83059-0107 is the product NDC for Severe Sinus Congestion and Pain, Acetaminophen 325 mg/1 + 2 more ingredients tablet, coated, listed with the FDA by Shield Pharmaceuticals Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Severe Sinus Congestion and Pain (Acetaminophen, Guaifenesin, Phenylephrine).
- What is the active ingredient?
- Acetaminophen, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Shield Pharmaceuticals Corp, NDC labeler code 83059. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Severe Sinus Congestion and Pain?
- 4 other product NDCs are listed under this name. See all Severe Sinus Congestion and Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Severe Sinus Congestion and Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Severe Sinus Congestion and Painacetaminophen, guaifenesin, phenylephrine | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0183 | 83059-0183-01 |
| Severe Sinus Congestion and Painacetaminophen, guaifenesin, phenylephrine | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0121 | 83059-0121-06 |
| Severe Sinus Congestion and Painacetaminophen, guaifenesin, phenylephrine | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0057 | 83059-0057-01 |
| Severe Sinus Congestion and Painacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-071 | 63868-0071-24 |
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 |
Showing 20 of 40.