Mineral Oil
- Product NDC
- 0363-0831
- 11-digit product format
- 003630831
- Labeler code
- 0363
- Product ID
- 0363-0831_4aa56d25-649f-b048-e063-6294a90afe2a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral Oil
- Dosage form
- LIQUID
- Route
- ORAL; TOPICAL
- Labeler
- Walgreen Co.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1994-06-16
- 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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T5L8T28FGP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 705909 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 822fd02a-92b0-4010-8bfb-737dba331d54 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0831-43 | Mineral Oil | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0831-43 | ML - Milliliter | 0363-0831 | 02874055-05cb-4008-94c7-0383702c46f7 | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | MINERAL OIL LIQUID [WALGREEN CO] | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | MINERAL OIL LIQUID [WALGREEN CO] | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | MINERAL OIL LIQUID [WALGREEN CO] | 1 |
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 | DOCUSATE SODIUM | Bryant Ranch Prepack | 2c9a1fe7-b77b-436b-8701-9f95f642d001 | 2024-07-05 | Warnings | M007 |
| SENNA | SENNA | Precision Dose, Inc. | e637777e-a39d-4e2f-a95c-4f524aa122f7 | 2024-07-05 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | GERI-CARE PHARMACEUTICALS, CORP | 1c462af8-af1a-391c-e063-6394a90a8b49 | 2024-07-02 | Warnings | M007 |
| Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free | CALCIUM POLYCARBOPHIL | Amerisourcebergen Drug Corporation | 4911fb44-e070-46c1-8f90-b78ceb10e51e | 2024-06-28 | Warnings | M007 |
| Fleet | DOCUSATE SODIUM | C.B. Fleet Company, Inc. | 56a7b6c5-d674-4eed-91c2-77f7d18fff32 | 2024-06-27 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | WALMART INC. (see also Equate) | 2cf6c9bf-c318-445d-9306-5675b1d424b0 | 2024-06-26 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | WALMART INC. (see also Equate) | d9db24b5-e3b5-47f9-b86b-bc8d70896a11 | 2024-06-26 | Warnings | M007 |
| Stool Softener | DOCUSATE CALCIUM | Walgreens | 2791223a-7ac0-47e5-9a6a-4d9a02cfeb63 | 2024-06-25 | Warnings | M007 |
| Fleet | BISACODYL | C.B. Fleet Company, Inc. | 4e0d973f-e6dc-48d9-8df3-1d47c87840f1 | 2024-06-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | TOP CARE (Topco Associates LLC) | 3b184800-649b-45d0-9586-8055d6d7fe08 | 2024-06-20 | Warnings | M007 |
| Senna Laxative | SENNA LAXATIVE | Good Sense | 9393032e-4343-4ac5-8e91-36013e5ca089 | 2024-06-18 | Warnings | M007 |
| Stool Softener | STOOL SOFTENER | Good Sense | 64266195-1b07-42c2-98a7-d76c12f74776 | 2024-06-18 | Warnings | M007 |
| Stool Softener Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | United Natural Foods, Inc. dba UNFI | 6c8c7c46-3ded-4e89-8e16-30eeb72aa08b | 2024-06-14 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | United Natural Foods, Inc. dba UNFI | 50ca1ce2-885f-4b71-a5fb-90c2cf508ce6 | 2024-06-14 | Warnings | M007 |
| basic care stool softener | DOCUSATE SODIUM | Amazon.com Services LLC | 356a889f-ec23-4eb2-a25c-bbe609475155 | 2024-06-14 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | 88cc2575-27a1-4514-bc41-bd1eac283814 | 2024-06-13 | Warnings | M007 |
| Senna laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | 2b5e1f03-0182-4d1c-8ba0-b1008b1335ad | 2024-06-12 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 1b7edd67-7b14-4fdd-9821-637f4b3c3a2c | 2024-06-06 | Warnings | M007 |
| Senna | SENNOSIDES | Patrin Pharma, Inc. | a9f1ef8d-8700-481f-a709-972bb9d27153 | 2024-05-30 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | WALGREEN COMPANY | 5f9cd233-6c46-5b52-e053-2991aa0ab729 | 2024-05-23 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 705909 | mineral oil 99.9 % Oral Solution | PSN | 822fd02a-92b0-4010-8bfb-737dba331d54 | 16 |
| 705909 | mineral oil 999 MG/ML Oral Solution | SCD | 822fd02a-92b0-4010-8bfb-737dba331d54 | 16 |
| 705909 | mineral oil 99.9 % Oral Solution | SY | 822fd02a-92b0-4010-8bfb-737dba331d54 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0831-43 | 00363083143 | 473 mL in 1 BOTTLE, PLASTIC (0363-0831-43) | 473 ml | 1994-06-16 | 0000-00-00 | No | No | Current |