Over-the-counter drug · OTC MONOGRAPH DRUG
Prolaxa (Docusate sodium 250mg) NDC 53225-2001
Docusate sodium 250 mg/1 · Capsule, Liquid filled · Oral · Terrain Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53225-2001-1 | 53225200101 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (53225-2001-1)Marketed from Apr 15, 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
- Terrain PharmaceuticalsNDC labeler code 53225
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 007
- Marketing start
- Listing expires
- Identifiers
- Product ID 53225-2001_37683907-1819-da31-e063-6394a90acc44SPL ID 37683907-1819-da31-e063-6394a90acc44SPL set ID 32610e42-f352-09fd-e063-6394a90abff6RxCUI 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
N453225200101followed by a unit qualifier and the quantityPackage 53225-2001-01. 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 53225-2001
- What is NDC 53225-2001?
- 53225-2001 is the product NDC for Prolaxa (docusate sodium 250mg), Docusate sodium 250 mg/1 capsule, liquid filled, listed with the FDA by Terrain Pharmaceuticals. 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?
- Terrain Pharmaceuticals, NDC labeler code 53225. 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 | Advanced Rx of Tennessee, LLC | 80425-0540 | 80425-0540-01 |
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 Softener Laxativedocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | United Natural Foods, Inc. dba UNFI | 41163-241 |
| Milk Of Magnesiamagnesium hydroxide | Magnesium hydroxide 1200 mg/15mL | LiquidOral | DOLGENCORP, INC. | 55910-649 |
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Reliable 1 Laboratories LLC | 69618-086 |
| Magnesium Citrate | Magnesium citrate 1.745 g/29.6mL | LiquidOral | The Kroger Co. | 30142-899 |
| citromamagnesium citrate | Magnesium citrate 1.745 g/29.6mL | LiquidOral | Vi-Jon, LLC | 0869-0164 |
| Magnesium Citrate | Magnesium citrate 1.745 g/29.6mL | SolutionOral | Publix Super Markets, Inc. | 56062-264 |
| Careonepsyllium husk | Psyllium husk .52 g/1 | CapsuleOral | FOODHOLD USA | 41520-907 |
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-7167 |
| Sennosides, Docusate Sodium | Docusate sodium 50 mg/1; Sennosides 8.6 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0195 |
| Magnesium Citrate | Magnesium citrate 1.745 g/29.6mL | SolutionOral | Publix Super Markets, Inc. | 56062-266 |
| Mineral oil | Mineral oil 100 mg/100mL | OilOral | P & L Development, LLC | 49580-0334 |
| Purifi Hand Sanitizerbenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | Purifi LLC | 80659-301 |
| Stool Softener Laxativedocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0091 |
| CareOne Milk of Magnesia Cherrymagnesium hydroxide | Magnesium hydroxide 1200 mg/15mL | LiquidOral | Retail Business Services, LLC. | 72476-665 |
| Stool Softener Laxative Extra Strengthdocusate sodium | Docusate sodium 250 mg/1 | Capsule, Liquid filledOral | WALMART INC. (see also Equate) | 79903-073 |
| Dulcolax Pink Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Chattem, Inc. | 41167-0281 |
| Quality Choice Laxativesodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic, Unspecified form 7 g/118mL; Sodium phosphate, Monobasic, Unspecified form 19 g/118mL | EnemaRectal | Chain Drug Marketing Association | 83324-292 |
| Magnesium Citrate | Magnesium citrate 1.745 g/29.6mL | LiquidOral | STRATEGIC SOURCING SERVICES | 70677-1112 |
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 72162-2255 |
| Milk of Magnesia Concentratemagnesium hydroxide | Magnesium hydroxide 2400 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0940 |
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