Pure and Gentle Laxative
- Product NDC
- 53329-014
- 11-digit product format
- 533290014
- Labeler code
- 53329
- Product ID
- 53329-014_27d44bbd-bd6d-844e-e063-6394a90a6273
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium phosphate
- Dosage form
- ENEMA
- Route
- RECTAL
- Labeler
- Medline Industries, LP
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-04-09
- Substance
- SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
- Active strength
- 7; 19 g/118mL; g/118mL
- 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 Laxative
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM PHOSPHATE, DIBASIC | 7 g/118mL |
| SODIUM PHOSPHATE, MONOBASIC | 19 g/118mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GR686LBA74, 3980JIH2SW |
| Rxcui | 283100 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53329-014-11 | Pure and Gentle Laxative | 1 in 1 BOX | ENEMA | 1 | | 13 |
| 53329-014-11 | Pure and Gentle Laxative | 133 mL in 1 BOTTLE | ENEMA | 133 | | 13 |
| 53329-014-58 | Pure and Gentle Laxative | 133 mL in 1 BOTTLE | ENEMA | 133 | | 13 |
| 53329-014-58 | Pure and Gentle Laxative | 24 in 1 CASE | ENEMA | 24 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM PHOSPHATE, DIBASIC | ACTIVE INGREDIENT | GR686LBA74 | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
| SODIUM PHOSPHATE, MONOBASIC | ACTIVE INGREDIENT | 3980JIH2SW | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
| PHOSPHATE ION | ACTIVE MOIETY | NK08V8K8HR | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-014 | PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, LP] | 13 | Current NDC, Legacy NDC, 4 package rows | 20241127_e3165538-75dd-4f0f-adc8-d4075de10f1e.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 283100 | sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema | PSN | e3165538-75dd-4f0f-adc8-d4075de10f1e | 13 |
| 283100 | sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema | SCD | e3165538-75dd-4f0f-adc8-d4075de10f1e | 13 |
| 283100 | sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema | SY | e3165538-75dd-4f0f-adc8-d4075de10f1e | 13 |
| 283100 | sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema | SY | e3165538-75dd-4f0f-adc8-d4075de10f1e | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53329-014-11 | 53329001411 | 1 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE | 1 bottle | 2017-11-10 | 0000-00-00 | No | No | Current |
| 53329-014-58 | 53329001458 | 24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE | 24 bottle | 2017-11-03 | 0000-00-00 | No | No | Current |