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 |
|---|---|---|---|---|---|---|
| Mineral Oil | MINERAL OIL | United Natural Foods, Inc. dba UNFI | cb7bc571-295f-47c2-ae93-18cba194752c | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Strategic Sourcing Services LLC | e4965086-dcc0-4b34-bb30-81facf7139f3 | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Valu Merchandisers Company | cd3e5836-b2f0-41f3-8623-3105c4642491 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Valu Merchandisers Company | a693f6b0-0679-4609-9ca0-dddfa4158c02 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Valu Merchandisers Company | fb358bc3-e479-42e7-8aea-a6a3676f2430 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Valu Merchandisers Company | ff539c1c-9ed3-49be-9b30-1858f12e1e90 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | United Natural Foods, Inc. dba UNFI | bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Walgreens SmoothLAX Soft Chews | MAGNESIUM HYDROXIDE | Walgreens | 424e27ce-0b11-9cd2-e063-6294a90a3c21 | 2026-02-16 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | da013c15-3531-4dc5-b122-bfc99bc494ae | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | db1bc651-1a35-4f92-a917-c6a19f421594 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b | 2026-02-13 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | b2ec06b3-647d-49ab-a392-6db63d96d1e3 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Topco Associates LLC | 5643f2e0-93e2-4c2e-90a0-fd152150d18a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Topco Associates LLC | d3cc7cb6-098e-413c-b1ad-7ebf5fa35269 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Topco Associates LLC | bc89c4bc-5207-479d-9a3b-e570b412a7ba | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | 72f69aa0-381a-4e5c-975d-3a73fdc1b377 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Topco Associates LLC | e9b1fd61-c229-4529-82c2-d6ac5b076082 | 2026-02-13 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Pinnacle RX LLC | 4abbb0e4-e005-bc4e-e063-6394a90a126a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| 365 Whole Foods Market Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market, Inc. | 4147cdd0-57f6-3857-e063-6394a90afecb | 2026-02-12 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Your Military Exchanges | 27cff497-123c-424a-9c43-57740c00168b | 2026-02-12 | Warnings, Adverse reactions | 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 |