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 |
|---|---|---|---|---|---|---|
| CVS Gentle Laxative | BISACODYL | CVS Pharmacy | 0cca1516-fc8d-4471-bd37-a6230fd225e2 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Gentle Laxative | BISACODYL | RITE AID PHARMACY | 0fb853db-8d97-64d6-e063-6294a90abeb5 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fb8f488-3386-29b9-e063-6294a90a014c | 2026-01-14 | Warnings | M007 |
| Rite-Aid Childrens Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fbe4dfd-1d5d-fc31-e063-6394a90ab317 | 2026-01-14 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 92659389-c36f-499b-b284-5b520e50e9a6 | 2026-01-14 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | AVPAK | af75d33f-b081-4b9d-bc12-d2829fa1f0cf | 2026-01-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | 597d2e9c-1adb-4c7d-ada3-de5c2db69c74 | 2026-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Mineral oil Laxative | MINERAL OIL | Strategic Sourcing Services LLC | ea6da66c-6825-4cd7-8791-45b537bf203a | 2026-01-08 | Warnings | M007 |
| Sunmark Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 06720229-7d58-499e-b7de-cb4bda5ae416 | 2026-01-08 | Warnings | M007 |
| HealthMart Mineral Oil Single Laxative | MINERAL OIL | Strategic Sourcing Services LLC | 1238ec69-1ea3-4773-9f13-71f0ae0a3553 | 2026-01-08 | Warnings | M007 |
| HealthMart Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 689228de-1f3e-4205-853d-6004d6248857 | 2026-01-08 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | c445864f-fc88-4885-9f40-d189b9dc4290 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | c46a1f7c-12e3-4be1-b9e4-d3edac0f4386 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 44fe6ce0-5fed-418f-8a6a-d6132e288328 | 2026-01-07 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Strategic Sourcing Services LLC | 24e29f00-f1cf-4e92-bd67-3f6f820af783 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 33000a06-e030-433a-8f9c-7ae5c08037fa | 2026-01-06 | Warnings | M007 |
| Stool Softener Regular Strength | DOCUSATE SODIUM | Sam's West, Inc | 1eca5910-b0bf-4e07-8211-36dba52b3de7 | 2026-01-06 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Major Pharmaceuticals | c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5 | 2026-01-05 | Warnings | M007 |
| GeriCare Sorbitol Solution | SORBITOL | GERI-CARE PHARMACEUTICALS, CORP | b4dd7a41-380e-d94b-e053-2a95a90ac34a | 2025-12-31 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c | 2025-12-31 | 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 |