Poly Hist Forte
- Product NDC
- 50991-626
- 11-digit product format
- 509910626
- Labeler code
- 50991
- Product ID
- 50991-626_1cda46d8-607e-048a-e063-6394a90a6d65
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate and Phenylephrine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-01
- Substance
- DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10.5; 10 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Poly Hist Forte
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYLAMINE SUCCINATE | 10.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V9BI9B5YI2, 04JA59TNSJ |
| Rxcui | 2172491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-626-01 | Poly Hist Forte | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 50991-626-02 | Poly Hist Forte | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 50991-626-02 | Poly Hist Forte | 12 in 1 CARTON | TABLET | 12 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-626 | POLY HIST FORTE (DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [POLY PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240711_8aa0015b-8fc1-7951-e053-2a95a90a8e72.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50991-626-01 | 50991062601 | 100 TABLET in 1 BOTTLE (50991-626-01) | 100 tablet | 2019-06-01 | 0000-00-00 | No | No | Current |
| 50991-626-02 | 50991062602 | 12 BLISTER PACK in 1 CARTON (50991-626-02) / 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2019-06-01 | 0000-00-00 | No | No | Current |