Over-the-counter drug · ANDA
Childrens Robitussin 12 Hour Cough Relief (Dextromethorphan polistirex) NDC 0031-8726
Dextromethorphan hydrobromide 30 mg/5mL · Suspension, Extended release · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-8726-10 | 00031872610 | 1 BOTTLE in 1 CARTON (0031-8726-10) / 89 mL in 1 BOTTLEMarketed from Jul 5, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Childrens Robitussin 12 Hour Cough Relief
- Generic name (nonproprietary)
- dextromethorphan polistirex
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/5mL
- Dosage form
- Suspension, Extended release
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0031
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091135
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0031-8726_159adf0d-831e-3d0e-e063-6394a90a40ddSPL ID 159adf0d-831e-3d0e-e063-6394a90a40ddSPL set ID 6bcad434-5714-443c-ba83-ed534df9f20aRxCUI 1373045UNII 9D2RTI9KYH
- 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
N400031872610followed by a unit qualifier and the quantityPackage 00031-8726-10. 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 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 0031-8726
- What is NDC 0031-8726?
- 0031-8726 is the product NDC for Childrens Robitussin 12 Hour Cough Relief, Dextromethorphan hydrobromide 30 mg/5mL suspension, extended release, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Robitussin 12 Hour Cough Relief (Dextromethorphan polistirex).
- What is the active ingredient?
- Dextromethorphan hydrobromide.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Robitussin 12 Hour Cough Relief?
- 1 other product NDC are listed under this name. See all Childrens Robitussin 12 Hour Cough Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Robitussin 12 Hour Cough Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Haleon US Holdings LLC | 0031-8725 | 00031-8725-10 |
Other NDCs under ANDA 091135
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 |
|---|---|---|---|---|
| 12 Hr Relief Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-263 |
| 12 hr relief cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-943 |
| basic care childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-899 |
| basic care childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-958 |
| basic care cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-384 |
| basic care cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Amazon.com Services LLC | 72288-494 |
| CareOne Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | American Sales Company | 41520-384 |
| CareOne Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | American Sales Company | 41520-958 |
| Childrens 12 Hr Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-429 |
| childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Walgreen Company | 0363-0899 |
| Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Haleon US Holdings LLC | 0031-8725 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Walgreen Company | 0363-0384 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Walgreen Company | 0363-0494 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Major Pharmaceuticals | 0904-6312 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6312 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Safeway | 21130-538 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Kroger Company | 30142-384 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Kroger Company | 30142-494 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | H E B | 37808-384 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Meijer Distribution Inc | 41250-384 |
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