Over-the-counter drug · OTC MONOGRAPH DRUG
Prolaxa (Docusate sodium 250mg) NDC 80425-0540
Docusate sodium 250 mg/1 · Capsule, Liquid filled · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0540-1 | 8042505400180425054001 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (80425-0540-1)Marketed from Aug 5, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Prolaxa
- Generic name (nonproprietary)
- docusate sodium 250mg
- Active ingredients
- Docusate sodium — 250 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 007
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0540_3ba0c7e2-c13b-a7d7-e063-6394a90abf07SPL ID 3ba0c7e2-c13b-a7d7-e063-6394a90abf07SPL set ID 3ba0c0d9-9e6f-a2e6-e063-6394a90a202dRxCUI 1245468, 2711894UNII F05Q2T2JA0
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
N480425054001followed by a unit qualifier and the quantityPackage 80425-0540-01. 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 for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours
Excerpt only. Read the full label for complete information.
About NDC 80425-0540
- What is NDC 80425-0540?
- 80425-0540 is the product NDC for Prolaxa (docusate sodium 250mg), Docusate sodium 250 mg/1 capsule, liquid filled, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prolaxa (Docusate Sodium 250mg).
- What is the active ingredient?
- Docusate sodium.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prolaxa?
- 1 other product NDC are listed under this name. See all Prolaxa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prolaxa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prolaxadocusate sodium 250mg | Docusate sodium 250 mg/1 | Capsule, Liquid filledOral | Terrain Pharmaceuticals | 53225-2001 | 53225-2001-01 |
Other NDCs under M 007
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 |
|---|---|---|---|---|
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-938 |
| Glycerin | Glycerin 1 g/1 | SuppositoryRectal | Chain Drug Consortium LLC | 68016-161 |
| Bisacodyl | Bisacodyl 10 mg/1 | SuppositoryRectal | CVS Pharmacy | 69842-816 |
| Mineral oil | Mineral oil 100 mg/100mL | OilOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-035 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate, Unspecified 1 g/g | GranuleOral, Topical | Whole Foods Market | 42681-6412 |
| Stratuscare Glycerin Laxative Pediatricglycerin | Glycerin 1 g/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-409 |
| Senokotstandardized senna concentrate | Sennosides 8.6 mg/1 | TabletOral | Atlantis Consumer Healthcare, Inc. | 67618-300 |
| Senna | Sennosides a and b 8.8 mg/5mL | SolutionOral | Rugby Laboratories | 0536-1483 |
| Milk Of Magnesia Cherrymagnesium hydroxide | Magnesium hydroxide 1200 mg/15mL | LiquidOral | TOP CARE (TOPCO ASSOCIATES LLC) | 36800-684 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate, Unspecified 1 g/g | GranuleOral, Topical | Whole Foods Market | 42681-6413 |
| Stratuscare Adult Glyceringlycerin | Glycerin 2 g/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-410 |
| Phillips Fresh Mint Milk Of Magnesia | Magnesium hydroxide 1200 mg/15mL | LiquidOral | Bayer HealthCare LLC. | 0280-0031 |
| Senokot-Sstandardized senna concentrate and docusate sodium | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | TabletOral | Atlantis Consumer Healthcare, Inc. | 67618-310 |
| Senexon-Sdocusate sodium 50mg and sennosides 8.6mg | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | Tablet, Film coatedOral | RUGBY LABORATORIES | 0536-1247 |
| Equate Kids Gentle Laxative SCmagnesium hydroxide | Magnesium hydroxide 1200 mg/1 | Tablet, ChewableOral | Walmart | 79903-252 |
| Stratuscare Bisacodylbisacodyl | Bisacodyl 10 mg/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-415 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate heptahydrate 1 g/g | Granule, For solutionOral, Topical | Vi-Jon, LLC | 0869-0602 |
| Fleetbisacodyl | Bisacodyl 5 mg/1 | Tablet, CoatedOral | C.B. Fleet Company, Inc. | 0132-0401 |
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-421 |
| Stool Softener Extra Strengthdocusate sodium | Docusate sodium 250 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-740 |
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