OTC - ACTIVE INGREDIENT SECTION
Phenylephrine hydrochloride 0.25%.............................Vasoconstrictor
Witch hazel 50.0%.....................................................Astringent
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55910-603-61 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b98d-f6ea-e053-dbdaa90aa703 | drug facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-603-61 | REXALL HEMORRHOIDAL COOLING | 51 g in 1 TUBE | GEL | 51 | 1 | |
| 55910-603-61 | REXALL HEMORRHOIDAL COOLING | 1 in 1 CARTON | GEL | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| WITCH HAZEL | ACTIVE INGREDIENT | 101I4J0U34 | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| WITCH HAZEL | ACTIVE MOIETY | 101I4J0U34 | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| ANHYDROUS TRISODIUM CITRATE | INACTIVE INGREDIENT | RS7A450LGA | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | INACTIVE INGREDIENT | ZYD53NBL45 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SULISOBENZONE | INACTIVE INGREDIENT | 1W6L629B4K | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55910-603 | 55910-603-61 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | ZYD53NBL45 | GEL / TOPICAL | 231 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 240 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | FILM / SUBLINGUAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SYRUP / ORAL | 156 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / INTRAVENOUS | 900 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | POWDER, FOR SOLUTION / ORAL | 48 mg/5ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE / ORAL | 418.37 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SOLUTION / TOPICAL | 0.1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | TABLET / ORAL | 720 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, CHEWABLE / ORAL | 84 mg | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | TABLET, CHEWABLE / ORAL | 72.5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ELIXIR / ORAL | 2.5 mg/15ml | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| ANHYDROUS TRISODIUM CITRATE | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | TABLET / SUBLINGUAL | 36 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, COATED / ORAL | 18 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRALESIONAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg |
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 |
|---|---|---|---|---|---|---|
| e6cb14cb-b299-4697-a448-a98a4f161064 | fde1627c-b40b-4a35-830f-bf791c64f84b | 2010-11-18 | Warnings | e6cb14cb-b299-4697-a448-a98a4f161064 fde1627c-b40b-4a35-830f-bf791c64f84b |
Adverse event summaries are temporarily unavailable. Other product information remains available.