Indications and uses
Traumeel Ear Drops Rx is indicated for the treatment of pain due to inflammation of otitis media and externa.
Traumeel Ear Drops Rx is indicated for the treatment of pain due to inflammation of otitis media and externa.
Adults and children 6 years and over: pour contents of 1 vial directly into the affected ear up to 3 times daily. Infants and children under 6 years: pour 1/2 of the contents of 1 vial into the affected ear up to 3 times daily.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50114-7110-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d08e-f6ea-e053-dbdaa90aa703 | Traumeel Ear Drops Rx |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50114-7110-1 | Traumeel | 10 in 1 CARTON | SOLUTION/ DROPS | 10 | 1 | |
| 50114-7110-1 | Traumeel | 0.45 mL in 1 VIAL, SINGLE-DOSE | SOLUTION/ DROPS | 0.45 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50114-7110 | TRAUMEEL (ARNICA MONTANA ROOT AND ATROPA BELLADONNA AND ACONITUM NAPELLUS AND HYPERICUM PERFORATUM AND CALENDULA OFFICINALIS FLOWERING TOP AND MATRICARIA RECUTITA AND ACHILLEA MILLEFOLIUM AND CALCIUM SULFIDE AND COMFREY ROOT AND BELLIS PERENNIS AND MERCURIUS SOLUBILIS AND ECHINACEA, UNSPECIFIED AND ECHINACEA PURPUREA AND HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) SOLUTION/ DROPS [HEEL INC] | 1 | Legacy NDC, 2 package rows | 20120606_d7c11bf7-632b-4a21-a1f8-2a0d17ec2b71.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACHILLEA MILLEFOLIUM | ACTIVE INGREDIENT | 2FXJ6SW4PK | 1 | |
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| ARNICA MONTANA ROOT | ACTIVE INGREDIENT | MUE8Y11327 | 1 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| BELLIS PERENNIS | ACTIVE INGREDIENT | 2HU33I03UY | 1 | |
| CALCIUM SULFIDE | ACTIVE INGREDIENT | 1MBW07J51Q | 1 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE INGREDIENT | 18E7415PXQ | 1 | |
| COMFREY ROOT | ACTIVE INGREDIENT | M9VVZ08EKQ | 1 | |
| ECHINACEA PURPUREA | ACTIVE INGREDIENT | QI7G114Y98 | 1 | |
| ECHINACEA, UNSPECIFIED | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK | ACTIVE INGREDIENT | T7S323PKJS | 1 | |
| HYPERICUM PERFORATUM | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| MERCURIUS SOLUBILIS | ACTIVE INGREDIENT | 324Y4038G2 | 1 | |
| ACHILLEA MILLEFOLIUM | ACTIVE MOIETY | 2FXJ6SW4PK | 1 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| ARNICA MONTANA ROOT | ACTIVE MOIETY | MUE8Y11327 | 1 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| BELLIS PERENNIS | ACTIVE MOIETY | 2HU33I03UY | 1 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE MOIETY | 18E7415PXQ | 1 | |
| COMFREY ROOT | ACTIVE MOIETY | M9VVZ08EKQ | 1 | |
| ECHINACEA PURPUREA | ACTIVE MOIETY | QI7G114Y98 | 1 | |
| ECHINACEA, UNSPECIFIED | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK | ACTIVE MOIETY | T7S323PKJS | 1 | |
| HYPERICUM PERFORATUM | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| MERCURIUS SOLUBILIS | ACTIVE MOIETY | 324Y4038G2 | 1 | |
| SULFIDE ION | ACTIVE MOIETY | G15I91XETI | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50114-7110 | 50114-7110-1 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / DENTAL | 0.4 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRABURSAL | 9 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SHAMPOO / TOPICAL | 150 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / AURICULAR (OTIC) | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRATHECAL | 131 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVITREAL | 6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAVITARY | 0.82 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / IONTOPHORESIS | 3.1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / TOPICAL | 0.32 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ENDOTRACHEAL | 7.6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAPERITONEAL | 0.54 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INHALANT / RESPIRATORY (INHALATION) | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / TOPICAL | 0.18 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVENOUS | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | JELLY / NASAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAMUSCULAR | 17 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RECTAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CREAM / TOPICAL | 0.4 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | IMPLANT / SUBCUTANEOUS | 77 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRASYNOVIAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRA-ARTICULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / SUBMUCOSAL | 17 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 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 |
|---|---|---|---|---|---|---|
| 68dcd90d-95e7-41e1-b527-449af5f287ab | d7c11bf7-632b-4a21-a1f8-2a0d17ec2b71 | 2012-05-23 | Warnings | 68dcd90d-95e7-41e1-b527-449af5f287ab d7c11bf7-632b-4a21-a1f8-2a0d17ec2b71 |
Adverse event summaries are temporarily unavailable. Other product information remains available.