Over-the-counter drug · OTC MONOGRAPH DRUG
Pyrilamine Maleate and Dextromethorphan Hydrobromide NDC 69367-398
Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL · Liquid · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-398-16 | 6936703981669367039816 | 473 mL in 1 BOTTLE (69367-398-16)Marketed from Jul 15, 2024 |
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)
- Pyrilamine Maleate and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- pyrilamine maleate and dextromethorphan hydrobromide
- Active ingredients
- Dextromethorphan hydrobromide — 7.5 mg/5mLPyrilamine maleate — 7.5 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- 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 69367-398_c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4SPL ID c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4SPL set ID dd068449-9d24-41e6-8a6e-f69c9fe263f2RxCUI 1423307UNII 9D2RTI9KYH, R35D29L3ZA
- 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
N469367039816followed by a unit qualifier and the quantityPackage 69367-0398-16. 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 due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation associated with a cold alleviates cough to help you sleep nonnarcotic cough suppressant for the relief of cough
Excerpt only. Read the full label for complete information.
About NDC 69367-398
- What is NDC 69367-398?
- 69367-398 is the product NDC for Pyrilamine Maleate and Dextromethorphan Hydrobromide, Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL liquid, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyrilamine Maleate and Dextromethorphan Hydrobromide.
- What is the active ingredient?
- Dextromethorphan hydrobromide, Pyrilamine maleate.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyrilamine Maleate and Dextromethorphan Hydrobromide?
- 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 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 |
| 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 |
| Daytime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-303 |
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