Over-the-counter drug · OTC MONOGRAPH FINAL
Severe Cold Head Congestion NDC 68998-175
acetaminophen, guaifenesin, and phenylephrine hydrochloride · Acetaminophen 325 mg/1 + 2 more ingredients · Tablet, Coated · Oral · Marc Glassman, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68998-175-02 | 6899801750268998017502 | 2 BLISTER PACK in 1 CARTON (68998-175-02) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Apr 1, 2015 |
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)
- Severe Cold Head Congestion
- Generic name (nonproprietary)
- acetaminophen, guaifenesin, and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Guaifenesin — 200 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Marc Glassman, Inc.NDC labeler code 68998
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 68998-175_7cebf003-9b2e-f398-e053-2a91aa0a62c2SPL ID 7cebf003-9b2e-f398-e053-2a91aa0a62c2SPL set ID 3a774544-1994-4a93-9da9-06e55b1a83c8RxCUI 1243679UNII 362O9ITL9D, 495W7451VQ, 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
N468998017502followed by a unit qualifier and the quantityPackage 68998-0175-02. 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 for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure 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 68998-175
- What is NDC 68998-175?
- 68998-175 is the product NDC for Severe Cold Head Congestion, Acetaminophen 325 mg/1 + 2 more ingredients tablet, coated, listed with the FDA by Marc Glassman, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Severe Cold Head Congestion (ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Marc Glassman, Inc., NDC labeler code 68998. 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 Cold Head Congestion?
- 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 part341
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 |
|---|---|---|---|---|
| Pseudo Time PEphenylephrine hchloride | Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC. | 49483-234 |
| Allergy Timechlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Time Cap Labs Inc | 49483-242 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-329 |
| CVS Health Sinus Reliefoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-787 |
| CVS Health Childrens Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | CVS Pharmacy,Inc. | 59779-793 |
| CVS Health Four Actions Nasal Decongestantphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-838 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Discount Drug Mart Value Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Drug Mart | 53943-256 |
| Pressure Pain Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-747 |
| NightTime Cold and Fluacetaminophen,dextromethorphan,doxylamine | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Velocity Pharma | 76168-056 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma LLC | 76168-121 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Pi Yuan Chinnaphazoline hydrochloride | Naphazoline hydrochloride 1 mg/1 | Solution/ dropsNasal | International Nature Nutraceuticals | 51367-035 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strengthdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | WALGREEN CO. | 0363-0758 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
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