Indications and uses
For the temporary relief of: Sleeplessness Restlessness Nervous tension and exhaustion
For the temporary relief of: Sleeplessness Restlessness Nervous tension and exhaustion
Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50114-1165-4 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d11e-f6ea-e053-dbdaa90aa703 | Valerianaheel Oral Drop |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50114-1165-4 | Valerianaheel | 50 mL in 1 BOTTLE | LIQUID | 50 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50114-1165 | VALERIANAHEEL (VALERIAN AND TRINITROPHENOL AND PRUNUS SPINOSA FLOWER BUD AND HOPS AND HYPERICUM PERFORATUM AND MELISSA OFFICINALIS AND AVENA SATIVA FLOWERING TOP AND MATRICARIA RECUTITA AND AMMONIUM BROMIDE AND POTASSIUM BROMIDE AND SODIUM BROMIDE) LIQUID [HEEL INC] | 1 | Legacy NDC, 1 package rows | 20120221_89c84354-e423-415c-bb31-dba20e4cc95f.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AMMONIUM BROMIDE | ACTIVE INGREDIENT | R0JB3224WS | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE INGREDIENT | MA9CQJ3F7F | 1 | |
| HOPS | ACTIVE INGREDIENT | 01G73H6H83 | 1 | |
| HYPERICUM PERFORATUM | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| MELISSA OFFICINALIS | ACTIVE INGREDIENT | YF70189L0N | 1 | |
| POTASSIUM BROMIDE | ACTIVE INGREDIENT | OSD78555ZM | 1 | |
| PRUNUS SPINOSA FLOWER BUD | ACTIVE INGREDIENT | 53Y84VPS2W | 1 | |
| SODIUM BROMIDE | ACTIVE INGREDIENT | LC1V549NOM | 1 | |
| TRINITROPHENOL | ACTIVE INGREDIENT | A49OS0F91S | 1 | |
| VALERIAN | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| AMMONIUM BROMIDE | ACTIVE MOIETY | R0JB3224WS | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE MOIETY | MA9CQJ3F7F | 1 | |
| BROMIDE ION | ACTIVE MOIETY | 952902IX06 | 1 | |
| HOPS | ACTIVE MOIETY | 01G73H6H83 | 1 | |
| HYPERICUM PERFORATUM | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| MELISSA OFFICINALIS | ACTIVE MOIETY | YF70189L0N | 1 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 1 | |
| PRUNUS SPINOSA FLOWER BUD | ACTIVE MOIETY | 53Y84VPS2W | 1 | |
| TRINITROPHENOL | ACTIVE MOIETY | A49OS0F91S | 1 | |
| VALERIAN | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50114-1165 | 50114-1165-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| VALERIAN | JWF5YAW3QW | ACTIB |
| TRINITROPHENOL | A49OS0F91S | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| PRUNUS SPINOSA FLOWER BUD | 53Y84VPS2W | ACTIB |
| HOPS | 01G73H6H83 | ACTIB |
| HYPERICUM PERFORATUM | XK4IUX8MNB | ACTIB |
| MELISSA OFFICINALIS | YF70189L0N | ACTIB |
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| AMMONIUM BROMIDE | R0JB3224WS | ACTIB |
| POTASSIUM BROMIDE | OSD78555ZM | ACTIB |
| SODIUM BROMIDE | LC1V549NOM | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 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 |
|---|---|---|---|---|---|---|
| 9f8cf8e1-df0f-43c5-ad97-f3ae07f5c127 | 89c84354-e423-415c-bb31-dba20e4cc95f | 2012-02-20 | Warnings | 9f8cf8e1-df0f-43c5-ad97-f3ae07f5c127 89c84354-e423-415c-bb31-dba20e4cc95f |
Adverse event summaries are temporarily unavailable. Other product information remains available.