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NDC 49348-0185-20 Sunmark Mineral Oil 118 g/118mL Details
Sunmark Mineral Oil 118 g/118mL
Sunmark Mineral Oil is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by McKesson. The primary component is MINERAL OIL.
Product Information
| NDC | 49348-0185 |
|---|---|
| Product ID | 49348-185_0994aef8-e264-4a79-be5e-3deb037cabd0 |
| Associated GPIs | 46400010005110 |
| GCN Sequence Number | 002996 |
| GCN Sequence Number Description | mineral oil ENEMA RECTAL |
| HIC3 | Q3S |
| HIC3 Description | LAXATIVES, LOCAL/RECTAL |
| GCN | 09049 |
| HICL Sequence Number | 001319 |
| HICL Sequence Number Description | MINERAL OIL |
| Brand/Generic | Generic |
| Proprietary Name | Sunmark Mineral Oil |
| Proprietary Name Suffix | Laxative |
| Non-Proprietary Name | Mineral Oil |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | ENEMA |
| Route | RECTAL |
| Active Ingredient Strength | 118 |
| Active Ingredient Units | g/118mL |
| Substance Name | MINERAL OIL |
| Labeler Name | McKesson |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49348-0185-20 (49348018520)
| NDC Package Code | 49348-185-20 |
|---|---|
| Billing NDC | 49348018520 |
| Package | 1 BOTTLE in 1 CARTON (49348-185-20) / 133 mL in 1 BOTTLE |
| Marketing Start Date | 2002-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01433 |
| Pricing Unit | ML |
| Effective Date | 2023-08-23 |
| NDC Description | SM READY TO USE ENEMA |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL c54f7df2-3845-425f-b13e-3dc000123f3c Details
Warnings
For rectal use only.
Ask a doctor before use if you have
- abdominal pain, nausea, or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Directions
Single daily dosage
Do not use more unless directed by a doctor. See Warnings.
| Adults and children 12 years old and over | 1 bottle |
| Children 2 to under 12 years old | 1/2 bottle once daily |
| Children under 2 years | DO NOT USE |
Other information
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
INGREDIENTS AND APPEARANCE
| SUNMARK MINERAL OIL
LAXATIVE
mineral oil enema |
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| Labeler - McKesson (116956644) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(49348-185) | |
Revised: 7/2020
Document Id: 0994aef8-e264-4a79-be5e-3deb037cabd0
Set id: c54f7df2-3845-425f-b13e-3dc000123f3c
Version: 3
Effective Time: 20200729