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 |
|---|---|---|---|---|---|---|
| Laxomil | BISACODYL 5MG | Pharmadel LLC | 3999935b-d8e8-52a6-e063-6294a90aa2a2 | 2026-03-20 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Grocery Outlet | c820e6a1-fa23-447a-9ee9-50a1bd617adb | 2026-03-19 | Warnings | M007 |
| CITRUCEL | METHYLCELLULOSE | Haleon US Holdings LLC | 9d5f2244-a610-4d45-b6e8-e79bb17a558f | 2026-03-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Safeway, Inc. | f178b31d-4843-4b91-a0d5-ab5ade835dc2 | 2026-03-16 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Safeway, Inc. | 12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c | 2026-03-13 | Warnings | M007 |
| Castor Oil | CASTOR OIL | Old East Main Co. | a1ca668a-3bf9-46a9-8a4f-5cb61547bb81 | 2026-03-12 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Vi-Jon, LLC | b29775df-8470-4fe3-bee3-f0490ea6903f | 2026-03-12 | Warnings | M007 |
| Castor Oil | CASTOR OIL | Nice-Pak Products, LLC | cc43d514-ee82-4314-99b2-c64380f98779 | 2026-03-12 | Warnings, Adverse reactions | M007 |
| Fibercon | CALCIUM POLYCARBOPHIL | Foundation Consumer Brands | 7992a4bb-5535-4a1d-867d-a99f7e0c1be7 | 2026-03-12 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | cda27a9c-9175-4b07-9c0b-d8d897882965 | 2026-03-12 | Warnings | M007 |
| Magnesium Citrate Saline Laxative - Lemon Flavor | MAGNESIUM CITRATE | Universal Distribution Center LLC | aa02c9af-22b8-4ec2-9e43-fe073f5e617b | 2026-03-11 | Warnings | M007 |
| Magnesium Citrate Saline Laxative - Grape Flavor | MAGNESIUM CITRATE | Universal Distribution Center LLC | 021ebb61-2466-4272-8f7d-b49cafd08754 | 2026-03-11 | Warnings | M007 |
| Magnesium Citrate Saline Laxative - Cherry Flavor | MAGNESIUM CITRATE | Universal Distribution Center LLC | 1f14411b-6833-40e6-b1a5-2b8c5bf709d3 | 2026-03-11 | Warnings | M007 |
| Citroma | MAGNESIUM CITRATE | UpLift Brands, LLC | f83ba007-734d-4910-87cb-02e45285e161 | 2026-03-11 | Warnings, Adverse reactions | M007 |
| Citroma | MAGNESIUM CITRATE | UpLift Brands, LLC | 57e914fa-8fa2-4221-bb5f-534f0ea0aba7 | 2026-03-11 | Warnings, Adverse reactions | M007 |
| Citroma | MAGNESIUM CITRATE | UpLift Brands, LLC | f28a9043-e0ee-4b38-95d9-d3f23d400691 | 2026-03-11 | Warnings, Adverse reactions | M007 |
| Stool Softener | DOCUSATE SODIUM | Amerisource Bergen | 4caf0bcb-c1bf-0ae7-e063-6294a90a344b | 2026-03-10 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 92df761b-da68-4ce9-b02a-a5a74fd6620e | 2026-03-10 | Warnings | M007 |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 31778652-e60e-4098-8e90-3e4f56b5800c | 2026-03-06 | Warnings | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 4c6094b7-c1ef-26a3-e063-6394a90af4cc | 2026-03-06 | 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 |