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 |
|---|---|---|---|---|---|---|
| SENNA TIME | SENNOSIDES | Bryant Ranch Prepack | bdcf37fc-3938-4d3f-b669-35c6939eac4f | 2026-07-10 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Preferred Pharmaceuticals Inc. | f8bba8cb-a111-4285-8bdb-2273a049c3bb | 2026-07-08 | Warnings | M007 |
| DOCUSATE SODIUM, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2026-07-06 | Warnings | M007 |
| Curewell Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | RMT HEALTH LLC | 55903043-2a1d-0525-e063-6394a90ae182 | 2026-07-01 | Warnings | M007 |
| Senna | SENNOSIDES 8.6 MG TABLETS | Aarkish Pharmaceuticals NJ Inc. | 564bc9a5-13b5-4cce-a349-6b2e122683ed | 2026-07-01 | Warnings | M007 |
| Senna-S | DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG | Aarkish Pharmaceuticals NJ Inc. | faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f | 2026-07-01 | Warnings | M007 |
| ENEMEEZ | DOCUSATE SODIUM | Quest Products, LLC | 0b06445d-0839-497e-bdff-e0fe224a7738 | 2026-06-30 | Warnings | M007 |
| ENEMEEZ Plus | DOCUSATE SODIUM AND BENZOCAINE | Quest Products, LLC | 1670ca59-7275-4ac6-bef4-674a7b24c7b3 | 2026-06-30 | Warnings | M007 |
| Mineral oil | MINERAL OIL | CVS Pharmacy, Inc. | 1183bcbc-51ec-e53a-e063-6394a90af0f2 | 2026-06-26 | Warnings, Adverse reactions | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552d9018-cc7d-7e1a-e063-6294a90a3322 | 2026-06-26 | Warnings | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552e16b9-f46a-7838-e063-6394a90ab8aa | 2026-06-26 | Warnings | M007 |
| Walgreens Gentle Laxative | BISACODYL SUPPOSITORY | Walgreens | 20c43036-830b-0e1d-e063-6394a90adf5f | 2026-06-25 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | American Health Packaging | be7cab51-ce7e-465d-95db-083e69288cfd | 2026-06-25 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Vi-Jon, LLC | ba490c22-19f0-4887-9509-bd3d32e0f5b1 | 2026-06-24 | Warnings, Adverse reactions | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | KROGER COMPANY | a1b0c638-6c34-1b72-e053-2995a90acc85 | 2026-06-24 | Warnings | M007 |
| Womens Laxative | WOMENS LAXTIVE | Allegiant Health | 549a11d1-a096-4c22-96b4-2d4f54f46022 | 2026-06-24 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Meijer Distribution Inc | f4259fda-19d4-087e-e053-2995a90a7081 | 2026-06-22 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Geri-Care Pharmaceuticals, Corp | 3ec42148-6786-22f2-e054-00144ff8d46c | 2026-06-18 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 546347e5-841e-15ca-e063-6294a90a0c8b | 2026-06-16 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 5463f869-2b92-4551-e063-6394a90ad6f9 | 2026-06-16 | 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 |