Over-the-counter drug · OTC MONOGRAPH DRUG
TexaClear Kids Allergy (Chlophedianol hcl pyrilamine maleate) NDC 58809-925
Chlophedianol hydrochloride 12.5 mg/30mL; Pyrilamine maleate 25 mg/30mL · Liquid · Oral · GM Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58809-925-08 | 5880909250858809092508 | 237 mL in 1 BOTTLE (58809-925-08)Marketed from Jun 15, 2016 |
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 Kids Allergy
- Generic name (nonproprietary)
- chlophedianol hcl pyrilamine maleate
- Active ingredients
- Chlophedianol hydrochloride — 12.5 mg/30mLPyrilamine maleate — 25 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- GM Pharmaceuticals, Inc.NDC labeler code 58809
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 12
- Marketing start
- Listing expires
- Identifiers
- Product ID 58809-925_413912d6-8c4d-3486-e063-6294a90a00bbSPL ID 413912d6-8c4d-3486-e063-6294a90a00bbSPL set ID 3b8a686f-d8e8-56db-e054-00144ff8d46cRxCUI 1808189UNII 69QQ58998Y, R35D29L3ZAUPC 0358809925087
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
N458809092508followed by a unit qualifier and the quantityPackage 58809-0925-08. 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: itchy nose or throat sneezing itchy, watery eyes runny nose cough due to minor throat and bronchial irritation
Excerpt only. Read the full label for complete information.
About NDC 58809-925
- What is NDC 58809-925?
- 58809-925 is the product NDC for TexaClear Kids Allergy (chlophedianol hcl pyrilamine maleate), Chlophedianol hydrochloride 12.5 mg/30mL; Pyrilamine maleate 25 mg/30mL liquid, 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 Kids Allergy (Chlophedianol HCl Pyrilamine Maleate).
- 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 Kids Allergy?
- 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 |
|---|---|---|---|---|
| TexaClearallergy relief | Chlophedianol hydrochloride 25 mg/1; Pyrilamine maleate 50 mg/1 | TabletOral | GM Pharmaceuticals, INC | 58809-186 |