Over-the-counter drug · OTC MONOGRAPH DRUG
Pure and Gentle (Mineral oil) NDC 53329-013
Mineral oil 100 g/100mL · Enema · Rectal · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-013-11 | 5332900131153329001311 | 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLEMarketed from Apr 9, 2014 |
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)
- Pure and Gentle
- Generic name (nonproprietary)
- mineral oil
- Active ingredients
- Mineral oil — 100 g/100mL
- Dosage form
- Enema
- Route
- Rectal
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 007
- Marketing start
- Listing expires
- Identifiers
- Product ID 53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6SPL ID 27d437bf-4b2b-eb33-e063-6394a90a4ef6SPL set ID 96d4cad5-0602-4c31-94ed-3117b4fd4a94RxCUI 205121UNII T5L8T28FGP
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N453329001311followed by a unit qualifier and the quantityPackage 53329-0013-11. 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 bowel movement in 2 to 15 minutes
Excerpt only. Read the full label for complete information.
About NDC 53329-013
- What is NDC 53329-013?
- 53329-013 is the product NDC for Pure and Gentle (mineral oil), Mineral oil 100 g/100mL enema, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pure and Gentle (Mineral oil).
- What is the active ingredient?
- Mineral oil.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pure and Gentle?
- 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 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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