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
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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health, 110 dba Leader | d27dc1cc-5e17-40d3-84fe-c1792552cfd5 | 2026-08-25 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ccec364a-3135-4a5d-b4b0-86b832387b4e | 2026-08-24 | Warnings | M007 |
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | a1591da0-a1a9-9583-3cf5-788b8fee3814 | 2026-08-24 | M007 | |
| MiraFAST soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 2cee67dd-b71f-32b8-e063-6394a90ae864 | 2026-08-21 | Warnings | M007 |
| Senokot-S | STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | c24cdc5e-62e0-41a6-8afb-512202a569f4 | 2026-08-21 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | d22fb02f-09c4-476a-b6d6-d3a2fd30049d | 2026-08-18 | Warnings | M007 |
| CVS Stool Softener Fruit Punch | DOCUSATE SODIUM | CVS PHARMACY, INC | 0e6900d6-7dc9-47d6-a006-1695feb8d5a5 | 2026-08-17 | Warnings | M007 |
| CVS Senna Laxative | SENNOSIDES | CVS PHARMACY | 5a5565b2-827f-4fcc-a835-d827f62da8f9 | 2026-08-17 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 306fd12b-ed60-40dc-a5be-2dc394bd29d2 | 2026-08-17 | Warnings | M007 |
| CVS Health Childrens Saline Laxative | MAGNESIUM HYDROXIDE | CVS PHARMACY,INC. | e57e5529-2190-4c66-8397-bc2848739e59 | 2026-08-14 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | Morepen Bio Inc | 562d1b9a-09d8-92fc-e063-6394a90a1993 | 2026-08-14 | Warnings | M007 |
| CVS Health | NATURAL FIBER SUPPLEMENT | CVS Pharmacy,Inc. | 04dbe9aa-ed18-4d76-a840-d010445a8643 | 2026-08-14 | Warnings | M007 |
| CVS Fiber Therapy | METHYLCELLULOSE | CVS PHARMACY | e066f5bd-5f34-4e04-beec-3c7d6db49381 | 2026-08-13 | Warnings | M007 |
| Mineral oil | MINERAL OIL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 92f2147d-b52d-4282-b217-28f6095dca0e | 2026-08-12 | Warnings | M007 |
| CAREONE Orange Flavored | PSYLLIUM HUSK | FOODHOLD USA | 4b1cccd2-e941-4d51-9924-4ca35e3a4429 | 2026-08-11 | Warnings | M007 |
| CAREONE | PSYLLIUM HUSK | FOODHOLD USA | 3ec3ead0-382e-4765-bbe8-b21e7c7b42a6 | 2026-08-11 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f4671579-aed0-4f93-ab83-248e0d72b5b0 | 2026-08-10 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | Aldama Pharmaceuticals, Inc | 492b6d37-47cf-3a28-e063-6294a90a2a18 | 2026-08-10 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Safeway Inc | 0b757160-f9eb-4413-9b43-97544c49c72f | 2026-08-10 | Warnings, Adverse reactions | M007 |
| Sennosides | SENNOSIDES | Cardinal Health 107, LLC | 4a9e1cbe-ffe4-462f-a86d-078a357dcf49 | 2026-08-07 | 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 |