LEADER Mineral Oil
- Product NDC
- 70000-0448
- 11-digit product format
- 700000448
- Labeler code
- 70000
- Product ID
- 70000-0448_3afc6408-65d9-be10-e063-6294a90aeb04
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral Oil
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Cardinal Health, 110 dba Leader
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-12-18
- Marketing end
- 2027-02-28
- Substance
- MINERAL OIL
- Active strength
- 1000 mg/mL
- NDC exclude flag
- No
- 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
- LEADER Mineral Oil
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINERAL OIL | 1000 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T5L8T28FGP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 343017 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7d4f8fa3-8203-5523-e053-2991aa0aba1a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0448-1 | LEADER Mineral Oil | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0448-1 | ML - Milliliter | 70000-0448 | b156330a-ea44-4e87-85fc-dc5516744199 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0448 | LEADER MINERAL OIL (MINERAL OIL) LIQUID [CARDINAL HEALTH, 110 DBA LEADER] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231223_7d4f8fa3-8203-5523-e053-2991aa0aba1a.zip |
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 Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | dcab26ff-2c10-4478-90a8-c89d87261bfa | 2024-03-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4d1391da-7874-4a51-a468-2843ecf6f92b | 2024-03-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | adaea845-e029-422d-a947-d8ce8f5787ed | 2024-03-18 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8b033d56-b95b-4905-9f33-cf2fbd61ce35 | 2024-03-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | CVS Pharmacy | 6a97a181-1ec2-473d-a588-db2f2f2f662d | 2024-03-14 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | CVS Pharmacy | dcd27653-4c81-4630-a8b7-5fb5dc3e976a | 2024-03-13 | Warnings | M007 |
| EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE | SENNOSIDES | Haleon US Holdings LLC | 62544c2f-6e30-4cec-ae63-233715ef0699 | 2024-03-13 | Warnings | M007 |
| Laxative Stool Softener | DOCUSATE SODIUM, SENNOSIDES | CVS Pharmacy | b52181e3-fd84-479e-8590-18619f6c0dae | 2024-03-13 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | CVS Pharmacy | 5eb047d2-8317-4de3-9268-d206ca039e3d | 2024-03-13 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | f77c65b0-3e13-48ce-a2d9-36a9eba1851f | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | 849b057a-dc46-423c-a2f4-b01f135a3803 | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE CALCIUM | CVS Pharmacy | cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | 8d59fa14-fc7c-4146-ba59-c2a907356dd6 | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Costco Wholesale | a19c20bd-84ff-4931-8312-2fbf0400e8e0 | 2024-03-06 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | a1ea0993-2d23-44e3-bc72-e4bf497ab723 | 2024-03-05 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Care One (Retail Business Services, LLC.) | a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f | 2024-03-05 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | eb7f3d65-8741-407d-b3f3-1d9dda19684d | 2024-03-05 | Warnings | M007 |
| Fleet | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC | C.B. Fleet Company, Inc. | f50ba829-16c3-40a7-9822-8d6d00353b33 | 2024-02-29 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 4ce62421-97e0-4920-9a6d-9fa1f0f93fe4 | 2024-02-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 851a5dda-e72b-4067-a98f-54d3222f646e | 2024-02-23 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 343017 | mineral oil 100 % Oral Solution | PSN | 7d4f8fa3-8203-5523-e053-2991aa0aba1a | 6 |
| 343017 | mineral oil 1000 MG/ML Oral Solution | SCD | 7d4f8fa3-8203-5523-e053-2991aa0aba1a | 6 |
| 343017 | mineral oil 100 % Oral Solution | SY | 7d4f8fa3-8203-5523-e053-2991aa0aba1a | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70000-0448-1 | 70000044801 | 473 mL in 1 BOTTLE, PLASTIC (70000-0448-1) | 473 ml | 2018-12-18 | 2027-02-28 | No | No | Current |