EAR RX
- Product NDC
- 69390-001
- Requested package NDC
- 69390-001-01
- 11-digit product format
- 693900001
- Labeler code
- 69390
- Product ID
- 69390-001_d44a9ea9-4e01-ec6c-e053-2a95a90a2bd5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aconitum nap, Baryta carb, Belladonna, Calc carb, Capsicum, Carbo veg, Causticum, Chamomilla, Ferrum phos, Hepar sulph calc, Kali mur, Lachesis, Lycopodium, Mercurius sol, Natrum mur, Plantago, Pulsatilla, Silicea, Sulphur, Verbascum
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Miami Beach Pediatrics pa
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2015-11-23
- Substance
- ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ATROPA BELLADONNA; BARIUM CARBONATE; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; VERBASCUM THAPSUS
- Active strength
- 6; 12; 9; 10; 10; 9; 8; 9; 8; 6; 9; 12; 6; 9; 10; 9; 9; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EAR RX
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACONITUM NAPELLUS | 6 [hp_X]/mL |
| BARIUM CARBONATE | 12 [hp_X]/mL |
| ATROPA BELLADONNA | 9 [hp_X]/mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 10 [hp_X]/mL |
| CAPSICUM | 10 [hp_X]/mL |
| ACTIVATED CHARCOAL | 9 [hp_X]/mL |
| CAUSTICUM | 8 [hp_X]/mL |
| MATRICARIA RECUTITA | 9 [hp_X]/mL |
| FERROSOFERRIC PHOSPHATE | 8 [hp_X]/mL |
| CALCIUM SULFIDE | 6 [hp_X]/mL |
| POTASSIUM CHLORIDE | 9 [hp_X]/mL |
| LACHESIS MUTA VENOM | 12 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 6 [hp_X]/mL |
| MERCURIUS SOLUBILIS | 9 [hp_X]/mL |
| SODIUM CHLORIDE | 10 [hp_X]/mL |
| PLANTAGO MAJOR | 9 [hp_X]/mL |
| PULSATILLA VULGARIS | 9 [hp_X]/mL |
| SILICON DIOXIDE | 6 [hp_X]/mL |
| SULFUR | 6 [hp_X]/mL |
| VERBASCUM THAPSUS | 6 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U0NQ8555JD | Internal UNII lookup |
| 6P669D8HQ8 | Internal UNII lookup |
| WQZ3G9PF0H | Internal UNII lookup |
| 2E32821G6I | Internal UNII lookup |
| 00UK7646FG | Internal UNII lookup |
| 2P3VWU3H10 | Internal UNII lookup |
| DD5FO1WKFU | Internal UNII lookup |
| G0R4UBI2ZZ | Internal UNII lookup |
| 91GQH8I5F7 | Internal UNII lookup |
| 1MBW07J51Q | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
| VSW71SS07I | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| 324Y4038G2 | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| W2469WNO6U | Internal UNII lookup |
| I76KB35JEV | Internal UNII lookup |
| ETJ7Z6XBU4 | Internal UNII lookup |
| 70FD1KFU70 | Internal UNII lookup |
| C9TD27U172 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a8753f88-4b8a-472f-a4bd-f2e9cec83610 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69390-001-01 | EAR RX | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69390-001 | EAR RX (ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM) LIQUID [MIAMI BEACH PEDIATRICS PA] | 5 | Current NDC, Legacy NDC, 1 package rows | 20211230_a8753f88-4b8a-472f-a4bd-f2e9cec83610.zip |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| EAR RX | ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM | Miami Beach Pediatrics pa | a8753f88-4b8a-472f-a4bd-f2e9cec83610 | 2021-12-29 | Warnings | 69390-001-01 69390-001 69390000101 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69390-001-01 | 69390000101 | 30 mL in 1 BOTTLE, DROPPER (69390-001-01) | 30 ml | 2017-11-22 | 0000-00-00 | No | No | Current |