Mineral oil
- Product NDC
- 49580-0334
- 11-digit product format
- 495800334
- Labeler code
- 49580
- Product ID
- 49580-0334_6651c0e4-d583-401d-96c4-5cb5fe10bd97
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral oil
- Dosage form
- OIL
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-08-31
- Substance
- MINERAL OIL
- Active strength
- 100 mg/100mL
- 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 | 100 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T5L8T28FGP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 68e88119-1468-4ab7-a5fa-242d960d25df | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0334-6 | Mineral oil | 473 mL in 1 BOTTLE | OIL | 473 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49580-0334-6 | ML - Milliliter | 49580-0334 | ee164ae0-79e5-4245-8f4f-360fe24652f2 | 1 | 2024-05-16 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | MINERAL OIL OIL [AARON INDUSTRIES INC.] | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | MINERAL OIL OIL [AARON INDUSTRIES INC.] | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | MINERAL OIL OIL [AARON INDUSTRIES INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0334 | MINERAL OIL OIL [P & L DEVELOPMENT, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250224_68e88119-1468-4ab7-a5fa-242d960d25df.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 | DOCUSATE SODIUM | TARGET Corporation | 89106733-69f1-469b-9d07-f06ac09b2fb6 | 2024-04-02 | Warnings | M007 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | e0b7acab-add4-4daf-b1df-bb7cf5ca8e19 | 2024-04-01 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 89dc2063-6744-4412-89be-90990090b57c | 2024-03-19 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2322765d-6f08-48d4-a500-818a8a558f6f | 2024-03-19 | Warnings | M007 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49580-0334-6 | 49580033406 | 473 mL in 1 BOTTLE (49580-0334-6) | 473 ml | 2014-08-31 | 0000-00-00 | No | No | Current |