Pure and Gentle
- Product NDC
- 53329-013
- 11-digit product format
- 533290013
- Labeler code
- 53329
- Product ID
- 53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- mineral oil
- Dosage form
- ENEMA
- Route
- RECTAL
- Labeler
- Medline Industries, LP
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-04-09
- Substance
- MINERAL OIL
- Active strength
- 100 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Pure and Gentle
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINERAL OIL | 100 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T5L8T28FGP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 205121 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-013-11 | Pure and Gentle | 1 in 1 BOX | ENEMA | 1 | 8 | |
| 53329-013-11 | Pure and Gentle | 133 mL in 1 BOTTLE | ENEMA | 133 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-013-11 | ML - Milliliter | 53329-013 | b0d5e6df-8259-431e-8efb-0f5262262062 | 1 | 2022-05-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.] | 2 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.] | 2 |
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 |
|---|---|---|---|---|---|---|
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | H E B | ab995d9a-1e40-2b38-e053-2a95a90a87e4 | 2025-08-21 | Warnings | M007 |
| Senokot | STANDARDIZED SENNA CONCENTRATE | Atlantis Consumer Healthcare, Inc. | d5bf67e5-82c6-edbf-e9ec-e027fdd47c84 | 2025-08-20 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 330758d2-fc1a-50ce-e063-6294a90a7db1 | 2025-08-19 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES AND DOCUSATE SODIUM | American Health Packaging | 4b84d5d7-43cf-47bb-af59-088550c3a0bc | 2025-08-12 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Good Sense (Geiss, Destin & Dunn, Inc.) | 8066a52d-e683-47c1-905c-290d2d427acf | 2025-08-12 | Warnings | M007 |
| Prolaxa | DOCUSATE SODIUM 250MG | Advanced Rx of Tennessee, LLC | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 2025-08-05 | Warnings | M007 |
| Dulcolax Stool Softener | DOCUSATE SODIUM | Chattem, Inc. | 86cb7102-3585-4757-9c37-5bf9776bbe63 | 2025-08-01 | Warnings | M007 |
| LEADER Mineral Oil | MINERAL OIL | Cardinal Health, 110 dba Leader | 7d4f8fa3-8203-5523-e053-2991aa0aba1a | 2025-07-28 | Warnings | M007 |
| Rapidol Sal Inglesa | MAGNESIUM SULFATE HEPTAHYDRATE | Pharmadel LLC | 1d4ef5f0-54c5-4838-e063-6394a90a44a8 | 2025-07-28 | Warnings | M007 |
| Enemeez Kids | DOCUSATE SODIUM | Quest Products LLC | f1602ba4-ad02-2936-e053-2995a90a27f2 | 2025-07-15 | Warnings | M007 |
| Sennosides | SENNOSIDES | Bryant Ranch Prepack | d4ab04e4-b78a-4afc-aa16-d9dc8fb6cc10 | 2025-07-14 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | Strategic Sourcing Services LLC | 1515fadd-a7a5-4502-afe2-cfcd50d5bfc8 | 2025-07-11 | Warnings | M007 |
| Quality Choice Fiber Caplets | CALCIUM POLYCARBOPHIL | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 29dbc831-23c1-487d-902a-9404d9ebe805 | 2025-07-09 | Warnings | M007 |
| Rexall Ready to use 4pk LAXATIVE | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Dolgencorp, LLC | 78509915-0ef1-4238-99a5-78a49a68f98f | 2025-07-07 | Warnings | M007 |
| Sal Inglesa EPSOM SALT | MAGNESIUM SULFATE HEPTAHYDRATE | Menper Distributors, Inc | 247aa3a3-d38f-4799-b44d-dfe18324fd0c | 2025-07-01 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | Chain Drug Consortium, LLC | 550000ba-0d6d-4666-8461-f591c14478b1 | 2025-06-27 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Chain Drug Consortium, LLC | c9807e6e-9dcc-41a2-8956-b61623ac2176 | 2025-06-27 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Chain Drug Consortium, LLC | 09449649-fd57-4446-8264-6c3bdd6621d0 | 2025-06-27 | Warnings | M007 |
| Senna | SENNOSIDES | Bryant Ranch Prepack | f2b14378-2b60-4533-b232-8c8647fbce78 | 2025-06-26 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET CORPORATION | 28fce2e2-2101-df88-e063-6394a90aa3de | 2025-06-25 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 205121 | mineral oil 100 % Enema | PSN | 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | 8 |
| 205121 | mineral oil 1000 MG/ML Enema | SCD | 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | 8 |
| 205121 | mineral oil 100 % Enema | SY | 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-013-11 | 53329001311 | 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE | 1 bottle | 2014-04-09 | 0000-00-00 | No | No | Current |