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 |
|---|---|---|---|---|---|---|
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | ee14dfe2-405f-493a-a774-ce1b01d05dd4 | 2026-05-05 | Warnings | M007 |
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Cardinal Health 107, LLC | 1a21b07a-263c-41a4-ba0c-ad2dc5a295d7 | 2026-05-05 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 4842a767-bb12-9d85-e063-6294a90a19b5 | 2026-04-27 | Warnings | M007 |
| Alcohol wet wipes | ALCOHOL WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f79dbac0-cec0-46bc-e053-6294a90a2b13 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f7ca1799-eee4-66f0-e053-6294a90a273f | 2026-04-25 | Warnings | M007 |
| Wet wipes | WET WIPES | JINGXIN GROUP (M) SDN BHD | 395225b1-486b-1867-e063-6394a90a1865 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | JINGXIN GROUP (M) SDN BHD | 3952873e-5e3f-1bff-e063-6294a90a8a62 | 2026-04-25 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Publix Supermarkets, Inc. | ed50555f-b105-45c8-9dc4-1bd4d233a1e3 | 2026-04-23 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Publix Supermarkets, Inc. | 382a57d1-85bf-480f-9967-f85da2904410 | 2026-04-23 | Warnings | M007 |
| BISACODYL | BISACODYL | AARNA USA INC. | 50109967-69af-5fc5-e063-6394a90a8751 | 2026-04-22 | Warnings | M007 |
| Senna | SENNA | Rugby Laboratories | 41d53783-7ac2-411c-b9bf-afd87b3af30d | 2026-04-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | 95bae7bf-f240-4674-9e3c-640a603fdc35 | 2026-04-15 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | a4b442f1-d5a6-4cbf-b371-1f6639634f80 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | 267c434d-3034-491b-b4b1-1d0cbacb1615 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | d616685a-11fc-4ae0-80de-7d25c0d71ee9 | 2026-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 84116db2-a7b7-460a-a5e5-8558bd424781 | 2026-04-02 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | American Health Packaging | 7d7d789b-b2e7-4600-a025-0cd2ff5b3672 | 2026-04-02 | Warnings | M007 |
| Castor Oil | CASTOR OIL | STRATEGIC SOURCING SERVICES | 4db6736f-416a-f142-e063-6394a90ab08f | 2026-04-01 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Farmacias De Similares TX LLC | 4e6a64a0-e453-709b-e063-6294a90a7443 | 2026-04-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | 93ef6486-0930-41e3-a2c6-44af7e37e98b | 2026-03-31 | 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 |