NDC 50991-626
Poly Hist Forte
Doxylamine Succinate And Phenylephrine Hydrochloride
Poly Hist Forte is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is Doxylamine Succinate; Phenylephrine Hydrochloride.
| Product ID | 50991-626_8a9ff45c-0e66-4821-e053-2a95a90a8139 |
| NDC | 50991-626 |
| Product Type | Human Otc Drug |
| Proprietary Name | Poly Hist Forte |
| Generic Name | Doxylamine Succinate And Phenylephrine Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-06-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Poly Pharmaceuticals, Inc. |
| Substance Name | DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 11 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 50991-626-01
100 TABLET in 1 BOTTLE (50991-626-01)
| Marketing Start Date | 2019-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50991-626-02 [50991062602]
Poly Hist Forte TABLET
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-06-01 |
NDC 50991-626-01 [50991062601]
Poly Hist Forte TABLET
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-06-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DOXYLAMINE SUCCINATE | 10.5 mg/1 |
OpenFDA Data
| SPL SET ID: | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "Poly Hist Forte" or generic name "Doxylamine Succinate And Phenylephrine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50991-216 | Poly Hist Forte | Doxylamine Succinate and Phenylephrine Hydrochloride |
| 50991-626 | Poly Hist Forte | Doxylamine Succinate and Phenylephrine Hydrochloride |
| 69367-199 | Doxylamine Succinate and Phenylephrine Hydrochloride | Doxylamine Succinate and Phenylephrine Hydrochloride |
Trademark Results [Poly Hist Forte]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLY HIST FORTE 76157717 2611825 Live/Registered |
Poly Pharmaceuticals, Inc. 2000-11-02 |
 POLY HIST FORTE 73718740 1550698 Dead/Cancelled |
POLY PHARMACEUTICALS, INC. 1988-03-25 |
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