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 |
|---|---|---|---|---|---|---|
| SENOKOT | STANDARDIZED SENNA | A-S Medication Solutions | 0c6e6bdd-9f49-4550-b60a-8f58b7c0f090 | 2026-09-09 | Warnings | M007 |
| Bisacodyl | BISACODYL | KROGER COMPANY | a13a8eec-3652-8c57-e053-2995a90aaebf | 2026-09-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 4180a35b-cc50-46ae-a100-99bb218c10ff | 2026-09-09 | Warnings | M007 |
| fiber laxative | PSYLLIUM HUSK | Raritan Pharmaceuticals Inc | 22e927bd-5734-424e-8870-1aaa18f1265e | 2026-09-08 | Warnings | M007 |
| DRx Choice Fiber Therapy | METHYLCELLULOSE | RARITAN PHARMACEUTICALS INC | 5e5749f7-074e-4bbc-9f33-5090e603fdb4 | 2026-09-08 | Warnings | M007 |
| Bisacodyl Stimulant Laxative | BISACODYL | Raritan Pharmaceuticals Inc | b99c1a6d-3034-4822-8540-210179c06857 | 2026-09-08 | Warnings | M007 |
| Daily Fiber Sugar Free | PSYLLIUM HUSK | Raritan Pharmaceuticals Inc | 9c4c41d8-a2d5-4168-9e97-9f9d47fc5e63 | 2026-09-08 | Warnings | M007 |
| DRx Choice Fiber Therapy | METHYLCELLULOSE | RARITAN PHARMACEUTICALS INC | 56c7f197-f01a-4611-a761-cda18da6eed0 | 2026-09-08 | Warnings | M007 |
| Sennosides 8.6 mg | SENNOSIDES | Morepen Bio Inc | 562c9f11-0ba1-011d-e063-6394a90a604a | 2026-09-05 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | 87f98e6c-a3a1-4ca5-bd56-977e38f48914 | 2026-09-04 | Warnings, Adverse reactions | M007 |
| Kroger Stool Softener Fruit Punch | DOCUSATE SODIUM | KROGER COMPANY | b86f8f3d-594e-466c-854a-b8bff9f7a0b8 | 2026-09-02 | Warnings | M007 |
| Oil | MINERAL OIL | Atlantic Biologicals Corp. | 5a82197b-281d-76c0-e063-6294a90a5746 | 2026-09-02 | Warnings, Adverse reactions | M007 |
| Kroger Senna Laxative Regular Strength | SENNOSIDES | KROGER COMPANY | dbb040bb-21f9-43e8-9705-689aeee4d04c | 2026-09-01 | Warnings | M007 |
| OneLAX SENNA | SENNA | Akron Pharma Inc. | 27fa8f54-ed84-4afd-8da3-8754da48643b | 2026-09-01 | Warnings | M007 |
| OneLAX Saline Laxative | MAGNESIUM CITRATE | AKRON PHARMA INC | 44c87bbc-2507-4b87-a74b-02f4acb30cf4 | 2026-09-01 | Warnings | M007 |
| OneLAX Saline Laxative | MAGNESIUM CITRATE | AKRON PHARMA INC | e6de00e6-dd81-4aab-af23-04fab261c6ff | 2026-09-01 | Warnings | M007 |
| EZ2Go Magnesium Citrate Saline Laxative Lemon Flavor | MAGNESIUM CITRATE | Valley Medical Products LLC | 5a71e88c-d8cc-a8bb-e063-6294a90af4f7 | 2026-09-01 | Warnings | M007 |
| Fiber Caplets | CALCIUM POLYCARBOPHIL | THE KROGER CO. | d6856f59-ccc3-40fc-9bf1-7a5394ed12da | 2026-09-01 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Your Military Exchanges | 6025dce6-02e8-418c-a248-0b5c33ff6067 | 2026-08-28 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Chain Drug Marketing Association | 583b64e7-e48d-6ba6-e063-6294a90ad4d7 | 2026-08-28 | Warnings, Adverse reactions | 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 |