Over-the-counter drug · ANDA
allergy relief d12 NDC 51316-572
fexofenadine hydrochloride, pseudoephedrine hydrochloride · Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-572-39 | 5131605723951316057239 | 30 BLISTER PACK in 1 CARTON (51316-572-39) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 2, 2026 | |
| 51316-572-60 | 5131605726051316057260 | 20 BLISTER PACK in 1 CARTON (51316-572-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 29, 2026 |
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)
- allergy relief d12
- Generic name (nonproprietary)
- fexofenadine hydrochloride, pseudoephedrine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216792
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-572_391b3d19-784c-478b-867d-8c8a38e83beeSPL ID 391b3d19-784c-478b-867d-8c8a38e83bee
- Pharmacologic class
- Histamine-1 Receptor Antagonist; alpha-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
N451316057239followed by a unit qualifier and the quantityPackage 51316-0572-39. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51316-572
- What is NDC 51316-572?
- 51316-572 is the product NDC for allergy relief d12, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- allergy relief d12 (Fexofenadine hydrochloride, pseudoephedrine hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
- Who is the labeler?
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for allergy relief d12?
- 1 other product NDC are listed under this name. See all allergy relief d12 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other allergy relief d12 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy Relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-607 | 51316-0607-5351316-0607-62 |
| allergy relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-4923 | 00363-4923-5300363-4923-62 |
Other NDCs under ANDA 216792
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 |
|---|---|---|---|---|
| Equate Allergy Relief Dfexofenadine hydrochloride, pseudoephedrine hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | WALMART INC. | 79903-424 |
| Foster And Thrive Allergy And Congestion Dfexofenadine hydrochloride, pseudoephedrine hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1315 |
| Leader 12Hr Allergy And Congestion Relieffexofenadine hydrochloride, pseudoephedrine hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0772 |
| Rugby Allergy Relief Dfexofenadine hydrochloride, pseudoephedrine hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rugby Laboratories | 0536-1491 |