NDC 0597-0016
Dulcolax
Docusate Sodium
Dulcolax is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Docusate Sodium.
| Product ID | 0597-0016_ac8d5286-b70b-d2b0-3526-79e42a106581 |
| NDC | 0597-0016 |
| Product Type | Human Otc Drug |
| Proprietary Name | Dulcolax |
| Generic Name | Docusate Sodium |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2002-10-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | DOCUSATE SODIUM |
| Active Ingredient Strength | 100 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0597-0016-56
1 BOTTLE in 1 CARTON (0597-0016-56) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE
| Marketing Start Date | 2002-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0597-0016-55 [00597001655]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2002-10-01 |
| Inactivation Date | 2020-01-31 |
NDC 0597-0016-56 [00597001656]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2002-10-01 |
| Inactivation Date | 2020-01-31 |
NDC 0597-0016-01 [00597001601]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2002-10-01 |
| Inactivation Date | 2020-01-31 |
NDC 0597-0016-25 [00597001625]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-05-13 |
| Marketing End Date | 2016-05-31 |
NDC 0597-0016-50 [00597001650]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2002-10-01 |
| Inactivation Date | 2020-01-31 |
NDC 0597-0016-26 [00597001626]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-02-01 |
| Inactivation Date | 2020-01-31 |
NDC 0597-0016-18 [00597001618]
Dulcolax CAPSULE, LIQUID FILLED
| Marketing Category | OTC monograph not final |
| Application Number | part334 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2002-10-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | 19a67966-be6c-409b-bbbe-33b0b8b65d65 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Dulcolax" or generic name "Docusate Sodium"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0012 | Dulcolax | Dulcolax |
| 0597-0052 | Dulcolax | Dulcolax |
| 0597-0016 | Dulcolax | Dulcolax |
| 0597-0162 | Dulcolax | Dulcolax |
| 0597-0340 | Dulcolax | Dulcolax |
| 29485-6741 | Dulcolax | Dulcolax |
| 0113-7004 | basic care stool softener | Docusate sodium |
| 0121-0544 | Docusate Sodium | Docusate Sodium |
| 0363-0655 | Gentle Stool Softener | Docusate sodium |
| 0113-0486 | good sense stool softener | Docusate sodium |
| 0363-6550 | Laxative | Docusate Sodium |
| 0132-0106 | Pedia-Lax | Docusate Sodium |
| 0280-1012 | Phillips Stool Softener | docusate sodium |
| 0363-0238 | Stool Softener | DOCUSATE SODIUM |
| 0363-0239 | Stool Softener | DOCUSATE SODIUM |
| 0363-5790 | Stool Softener | Docusate Sodium |
| 0363-8540 | Stool Softener | Docusate Sodium |
| 0363-0016 | Stool Softener Laxative | DOCUSATE SODIUM |
| 0363-0679 | Stool Softener Laxative | DOCUSATE SODIUM |
| 0363-4100 | Stool Softener Laxative | Docusate Sodium |
| 0363-4202 | Stool Softener Laxative | Docusate Sodium |
| 0363-8530 | Stool Softener Laxative | Docusate Sodium |
| 0363-7140 | Walgreens Stool Softener | Docusate sodium |
Trademark Results [Dulcolax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DULCOLAX 79043985 3505530 Live/Registered |
Sanofi-Aventis Deutschland GmbH 2007-08-16 |
 DULCOLAX 78157653 2861373 Dead/Cancelled |
Boehringer Ingelheim International GmbH 2002-08-26 |
 DULCOLAX 72042116 0671422 Live/Registered |
DR, KARL THOMAE GMBH 1957-12-10 |
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