Over-the-counter drug · OTC MONOGRAPH DRUG
TexaClear (Allergy relief) NDC 58809-186
Chlophedianol hydrochloride 25 mg/1; Pyrilamine maleate 50 mg/1 · Tablet · Oral · GM Pharmaceuticals, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58809-186-30 | 5880901863058809018630 | 30 TABLET in 1 BOTTLE (58809-186-30)Marketed from Dec 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)
- TexaClear
- Generic name (nonproprietary)
- allergy relief
- Active ingredients
- Chlophedianol hydrochloride — 25 mg/1Pyrilamine maleate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GM Pharmaceuticals, INCNDC labeler code 58809
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 12
- Marketing start
- Listing expires
- Identifiers
- Product ID 58809-186_47e5a8c0-5221-65e9-e063-6294a90a443bSPL ID 47e5a8c0-5221-65e9-e063-6294a90a443bSPL set ID 2a06e00a-0887-4386-e054-00144ff88e88RxCUI 1735487UNII 69QQ58998Y, R35D29L3ZAUPC 0358809186303
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
N458809018630followed by a unit qualifier and the quantityPackage 58809-0186-30. 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 the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose itchy, watery eyes itching of the nose or throat sneezing cough due to minor throat and bronchial irritation
Excerpt only. Read the full label for complete information.
About NDC 58809-186
- What is NDC 58809-186?
- 58809-186 is the product NDC for TexaClear (allergy relief), Chlophedianol hydrochloride 25 mg/1; Pyrilamine maleate 50 mg/1 tablet, listed with the FDA by GM Pharmaceuticals, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TexaClear (Allergy Relief).
- What is the active ingredient?
- Chlophedianol hydrochloride, Pyrilamine maleate.
- Who is the labeler?
- GM Pharmaceuticals, INC, NDC labeler code 58809. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TexaClear?
- 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 12
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 |
|---|---|---|---|---|
| TexaClear Kids Allergychlophedianol hcl pyrilamine maleate | Chlophedianol hydrochloride 12.5 mg/30mL; Pyrilamine maleate 25 mg/30mL | LiquidOral | GM Pharmaceuticals, Inc. | 58809-925 |