Mineral oil
- Product NDC
- 49035-035
- 11-digit product format
- 490350035
- Labeler code
- 49035
- Product ID
- 49035-035_abe12f54-7949-4ae8-90ba-0a5031c0fad3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral oil
- Dosage form
- OIL
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-31
- Marketing end
- 2027-08-28
- Substance
- MINERAL OIL
- Active strength
- 100 mg/100mL
- 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
- Mineral oil
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 |
|---|---|
| 92f2147d-b52d-4282-b217-28f6095dca0e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-035-16 | Mineral oil | 473 mL in 1 BOTTLE | OIL | 473 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-035-16 | ML - Milliliter | 49035-035 | 0ed63aee-ff71-4522-b2d8-6d26323cac66 | 1 | 2017-06-15 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | MINERAL OIL OIL [EQUATE (WALMART STORES, INC.)] | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | MINERAL OIL OIL [EQUATE (WALMART STORES, INC.)] | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | MINERAL OIL OIL [EQUATE (WALMART STORES, INC.)] | 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 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 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 2ca80e23-f38a-4f77-b536-131cc9f0cf5b | 2024-02-23 | Warnings | M007 |
| Colon Detox | DOCUSATE SODIUM AND SENNOSIDES | OPMX LLC | 0a4d3265-080c-d2ed-e063-6394a90adbee | 2024-02-21 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | Best Choice (Valu Merchandisers Company) | 4501d718-15a7-4e27-bdb1-8aa2d3ff06d0 | 2024-02-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Best Choice (Valu Merchandisers Company) | 72bd251b-4e82-41ef-8362-39f95faf9916 | 2024-02-15 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON | CARDINAL HEALTH, INC. 063997360 | 10bdd5e6-3db2-8f9e-e063-6394a90a9b3f | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | CARDINAL HEALTH, INC. 063997360 | 10beb3ec-a189-221d-e063-6394a90aabb5 | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | CARDINAL HEALTH, INC. 063997360 | 10bebb63-19b3-2e14-e063-6394a90a8d4e | 2024-02-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Proficient Rx LP | f9ac0344-5864-4ac1-81bc-16878a5946c5 | 2024-02-01 | Warnings | M007 |
| Purifi Hand Sanitizer | BENZALKONIUM CHLORIDE | Purifi LLC | 9267069d-4cf5-4e48-a446-7dbebea16bf5 | 2024-01-31 | Warnings | M007 |
| WOMENS LAXATIVE ENTERIC COATED | BISACODYL | CARDINAL HEALTH | ab34bc89-6738-d284-e053-2a95a90a5dc9 | 2024-01-11 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE | SENNOSIDES | CARDINAL HEALTH | b7b13bfa-8a94-6f62-e053-2995a90abbf4 | 2024-01-10 | Warnings | M007 |
| FIBER LAXATIVE | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | e4a921c5-1cf7-12ca-e053-2a95a90a6e04 | 2024-01-03 | Warnings | M007 |
| Freskaro Castor Oil | CASTOR OIL | Pharma Nobis, LLC | fbd6bdd5-a7a1-3f28-e053-6294a90aab87 | 2023-12-28 | Warnings | M007 |
| Humco Castor Oil | CASTOR OIL | Pharma Nobis, LLC | e42f9d37-1b07-177a-e053-2a95a90a9b06 | 2023-12-26 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Pharma Nobis, LLC | f0477328-eca1-9043-e053-2995a90aaa3d | 2023-12-22 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Pharma Nobis, LLC | f0489f6f-9e60-7d69-e053-2a95a90a9dfb | 2023-12-22 | Warnings | M007 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-035-16 | 49035003516 | 473 mL in 1 BOTTLE (49035-035-16) | 473 ml | 2014-10-31 | 2027-08-28 | No | No | Current |