Mineral Oil
- Product NDC
- 11344-831
- 11-digit product format
- 113440831
- Labeler code
- 11344
- Product ID
- 11344-831_5c13904a-5e3e-0a09-e063-6294a90a44ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral Oil
- Dosage form
- OIL
- Route
- ORAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-30
- Substance
- MINERAL OIL
- Active strength
- 999 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mineral Oil
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINERAL OIL | 999 mg/mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-831-43 | Mineral Oil | 473 mL in 1 BOTTLE, PLASTIC | OIL | 473 | 3 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stool Softener Extra Strength | DOCUSATE SODIUM | MEIJER, INC. | e43bd2ed-17c7-4530-af72-81a7ad70069c | 2023-10-12 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Care One (Retail Business Services, LLC.) | 9adaec97-43e3-48f2-96c8-c508b693676c | 2023-10-05 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | TopCo Associates, LLC | 83aeb90a-ab00-4e26-aa44-5259dce59018 | 2021-04-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 9fbe783e-ddd9-445a-852a-00f4ad754880 | 2021-04-20 | Warnings | M007 |
| Topcare Stool Softener | DOCUSATE SODIUM | TopCo Associates, LLC | 6f4fddda-4129-4087-b0e4-ababc5558484 | 2021-02-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 30c9ff75-cee4-4632-86fd-acfdf5ee85af | 2020-10-27 | Warnings | M007 |
| Stool Softener | MARC GLASSMAN | Marc Glassman, Inc. | 909cd222-d836-416f-aa7d-deb4a0c5a560 | 2020-09-08 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | Allegiant Health | 94a9c24a-07c3-4535-b810-b7abc9fc5ad5 | 2019-12-11 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Marc Glassman, Inc. | ec34fc1e-d122-4fa4-859e-e89e3e12edd5 | 2019-09-18 | Warnings | M007 |
| Womens Laxative | BISACODYL | Marc Glassman, Inc. | aeb3c49b-cbf5-4a47-b19c-e77fbb987a49 | 2019-09-17 | Warnings | M007 |
| Bisacodyl 5mg | BISACODYL 5MG | Allegiant Health | 46a377f5-822b-496f-a73b-66d8f902680a | 2019-03-26 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Allegiant Health | 51f1c6c0-770c-4426-820b-bc1f42e143fd | 2019-02-07 | Warnings | M007 |
| Senna-Lax | SENNOSIDES | Marc Glassman, Inc. | 7dd97c54-2ba1-4629-87b9-1ba0913fe531 | 2016-12-27 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 705909 | mineral oil 99.9 % Oral Solution | PSN | 3780aee2-7018-4c65-8991-be4e98b7339e | 3 |
| 705909 | mineral oil 999 MG/ML Oral Solution | SCD | 3780aee2-7018-4c65-8991-be4e98b7339e | 3 |
| 705909 | mineral oil 99.9 % Oral Solution | SY | 3780aee2-7018-4c65-8991-be4e98b7339e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-831-43 | 11344083143 | 473 mL in 1 BOTTLE, PLASTIC (11344-831-43) | 473 ml | 2024-04-30 | No | No | Current |